India Government may bring in new curbs on drug prices this month
NEW DELHI: The drug pricing mechanism in the country is likely to be overhauled before the end of this month. Among the changes proposed by the government is the move to introduce a new price index for pharmaceutical products that will become the benchmark to determine prices of all medicines sold in the country — even those that are currently outside the drug price control order. Even now, the government loosely regulates prices of all medicines in public interest. Prices of around 850 essential drugs are capped by the government. The drug price regulator National Pharmaceutical Pricing Authority (NPPA) revises these prices annually based on the wholesale price index (WPI). For all other medicines, companies are allowed to raise prices by no more than 10% in a year.
Mylan-Biocon’s insulin biosimilar faces FDA hurdle
The US drug regulator has cited issues with generics giant Mylan’s application seeking approval for copies of insulin glargine, a patented type-1 diabetes drug sold by French pharma major Sanofi
Soy lecithin NSAID combo drug protects against cancer with fewer side effects
When scientists at The University of Texas Health Science Center at Houston (UTHealth) applied a chemical found in soybeans to a non-steroidal anti-inflammatory drug (NSAID), they increased its anticancer properties and reduced its side effects. Findings of the preclinical study of phosphatidylcholine, also called lecithin, appear in the journal Oncology Letters.”The results support the potential use of NSAIDs associated with phosphatidylcholine for the prevention and treatment of colorectal cancer,” said Lenard Lichtenberger, Ph.D., the study’s lead investigator and a professor of integrative biology and pharmacology at McGovern Medical School at UTHealth.
New drugs could also be deployed against lung and pancreatic cancers
A new anti-cancer drug may be effective against a wider range of cancers than previously thought. Using a mouse model and samples taken from cancer patients, a team from the Technical University of Munich (TUM) has shown that a new class of drugs known as SHP2 inhibitors is also effective against aggressive, hard-to-treat tumors such as lung and pancreatic cancers. Clinical trials currently underway had previously excluded patients with these cancers.
Significant improvement in symptom frequency and quality of life domains with Entresto®
Novartis announced today new real world evidence from the CHAMP-HF registry comparing Entresto® (sacubitril/valsartan) patients to patients not taking Entresto. This pre-specified analysis of an interim data cut from the CHAMP-HF registry showed that chronic heart failure (HF) patients with reduced ejection fraction (HFrEF) taking Entresto reported early, statistically significant improvement in health status,
FDA Approves Aimovig™ (erenumab-aooe), A Novel Treatment Developed Specifically For Migraine Prevention
THOUSAND OAKS, Calif., May 17, 2018 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Aimovig™ (erenumab-aooe) for the preventive treatment of migraine in adults. Aimovig is a novel therapeutic approach as the first and only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R) – which is believed to play a critical role in migraine. Aimovig 70 mg is self-administered once monthly via Amgen’s device, the SureClick® autoinjector, and does not require a loading dose. Some patients may benefit from a dosage of 140 mg once monthly.
Mediclinic to acquire two Majid Al Futtaim clinics in Dubai
Mediclinic is set to acquire Dubai-based City Centre Clinics Deira and Me’aisem from Majid Al Futtaim.The agreement will allow Mediclinic Middle East the opportunity to partner with Majid Al Futtaim in future locations, the international private healthcare group said.City Centre Clinic Deira, a large outpatient facility, opened in 2013 with two day-care surgery theatres and 18 medical disciplines, and City Centre Clinic Me’aisem, is a smaller community clinic focusing on six core disciplines.
Takeda agrees to buy Shire in £46bn deal
Japan’s Takeda Pharmaceutical has struck a deal to buy Irish drugmaker Shire for £46bn after the two sides finally agreed the terms of the deal.The agreement ends a takeover battle that had seen Takeda make five offers for UK-listed Shire since late March.If the deal is backed by shareholders, it will be the largest overseas takeover by a Japanese company to date.The deal is part of Takeda’s strategy of becoming a global pharmaceutical company.
The top 10 drug patent expirations of 2018
1-RITUXAN® (rituximab) by Biogen 5- Advair (Seretide diskus)by GSK 9-Zytiga by Jansen
2-Lyrica by Pfizer 6-Neulasta by Amgen 10- sensipar by Amgen
3-Restasis by Allergan 7-Epogen/Procrit by Amgen
4-Xolair by Novartis 8- Cialis by lilly
Taiwanese company wins FDA approval for HIV treatment with new mechanism of action
While several classes of drugs have made HIV a manageable disease, there’s a small group of patients who develop resistance against multiple treatments. Now, the FDA has approved a Taiwanese company’s new drug that can address that resistance. Developed by TaiMed Biologics, Trogarzo (ibalizumab-uiyk) is the first HIV therapy with a novel mechanism of action in more than 10 years. A humanized monoclonal antibody, Trogarzo blocks the HIV virus from infecting host cells by binding to extracellular domain 2 of the CD4+ receptor, a site different from other antiretrovirals currently on the market. It is given intravenously once every 14 days and used in combination with other antiretrovirals.
SGLT2 diabetes drugs can cut the rate of major cardiovascular events
Last year, real-world data showed that SGLT2 diabetes drugs could significantly cut heart failure hospitalizations and all-cause deaths. And now, a new analysis shows they can also cut the rate of major cardiovascular events in patients new to treatment.High-risk diabetes patients who started on Johnson & Johnson’s Invokana, Eli Lilly and Boehringer Ingelheim’s Jardiance or AstraZeneca’s Farxiga saw their combined risk of heart attack, stroke and cardiovascular death plummet by 33%, according to a study based on data from the U.S. Department of Defense Military Health System and recently published in the journal Circulation.Patients’ risk of death or hospitalization for heart failure plunged by 43%, too.
Aster DM Healthcare to set up five new hospitals in India
Kochi’s Aster DM Healthcare, promoted by Dubai-based Indian healthcare billionaire Dr Azad Moopen, is planning a massive expansion to emerge as one of leading healthcare providers in India.Aster, with installed bed capacity of 3,983 across 11 multispecialty hospitals in the country, is planning to build or expand five hospitals within the next four years.
Pfizer exits China joint venture for generic drugs
Pfizer Inc said on Friday it has sold its 49 percent stake to exit a joint venture it had set up with China’s Zhejiang Hisun Pharmaceuticals in 2012 to develop and market generic drugs.The U.S. drugmaker said it sold its stake in the venture, Hisun-Pfizer Pharmaceuticals Co Ltd, to Sapphire I Holdings Ltd.
Novartis strengthens autoimmune indications for Cosentyx
Novartis has further strengthened Cosentyx’s (secukinumab) offering to patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA), following the emergence of long-term, positive III data.
Novartis to buy French cancer specialist AAA for $3.9 billion
Novartis has agreed to buy French-based Advanced Accelerator Applications (AAA) for $3.9 billion, giving it a platform in radiopharmaceuticals and access to a new therapy for the kind of cancer that killed Steve Jobs. The move fits with Novartis Chief Executive Joe Jimenez’s strategy of pursuing bolt-on deals worth up to around $5 billion rather than seeking out larger targets.
Gilead to Buy Kite, Maker of Cancer Treatments, for $11.9 Billion
The drugmaker Gilead Sciences said on Monday that it would buy Kite Pharma for about $11.9 billion to bolster its aging portfolio with an emerging cancer treatment.The acquisition, Gilead’s first major deal since 2011, is a departure from the path followed by the broader pharmaceutical industry, where — apart from Johnson & Johnson’s $30 billion takeover of the Swiss biotechnology company Actelion — the pace of acquisitions had largely slowed this year. Many drugmakers that had been busy with takeover activity in recent years have since been at work integrating their purchases.Under the terms of the agreement, Gilead will pay $180 a share in cash, a 29 percent premium to Kite’s closing price on Friday.
Lord, Abbett Sues Valeant pharmacutical Claims $80 Billion In Losses
Valeant has been hit by another legal bombshell. Mutual fund Lord, Abbett claims $80 billion in investor losses after it bought VRX shares at artificially high prices based on misinformation from Valeant:Lord Abbett & Co., the mutual fund company, filed a securities fraud lawsuit against Valeant on Wednesday alleging that it bought shares in the drug giant at an artificially high price because of misinformation provided by Valeant. The suit, filed in federal court in New Jersey and alleging violations of New Jersey’s racketeer influenced and corrupt organizations (RICO) law, represents a new and potentially costly legal attack on Valeant, which is already facing lawsuits over alleged manipulation of drug prices.
Novartis and Medicines for Malaria Venture launch patient trial in Africa for KAF156, a novel compound against multidrug-resistant malaria
Novartis and Medicines for Malaria Venture (MMV) have launched a patient trial for KAF156, a next-generation antimalarial compound with the potential to treat drug-resistant strains of the malaria parasite. The trial will test the efficacy of KAF156 in combination with a new, improved formulation of the existing antimalarial lumefantrine.
FDA approves Pfizer new treatment for adults with relapsed or refractory acute lymphoblastic leukemia.
The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). B-cell precursor ALL is a rapidly progressing type of cancer in which the bone marrow makes too many B-cell lymphocytes, an immature type of white blood cell. The National Cancer Institute estimates that approximately 5,970 people in the United States will be diagnosed with ALL this year and approximately 1,440 will die from the disease.
Enzyme discovery could improve treatments for obesity, related diseases
Harvard University researchers have unraveled a metabolic process—and the enzyme responsible for it—that protects cells from harmful fats. The discovery could lead to improved treatments for obesity and its related diseases.Triglycerides, a type of fat found in the human body, are broken down into fatty acids and then transported out of fat cells to other tissues in the body for energy. But unlike triglycerides, fatty acids can damage the endoplasmic reticulum, a cell component that makes cellular products, such as proteins and fats.Through a process called re-esterification, any leftover fatty acids in the fat cells turn back into triglycerides. This protects the endoplasmic reticulum and wards off inflammation in body fat.Looking at cell processes in mice and in human cells, the Harvard team found that the enzyme diacylglycerol acyltransferase (DGAT1) drives re-esterification. It behaves like a “cellular police officer” to guard the endoplasmic reticulum from fatty acids, researchers said in a statement. Until now, it was unknown why some triglycerides, after being broken down into acids, reassemble themselves. The research is published in Cell Metabolism
Celgene and Agios win FDA approval for targeted AML drug Idhifa
Patients with a specific type of acute myeloid leukemia have their first treatment option with the FDA’s accelerated approval Tuesday of Idhifa from partners Celgene and Axios.Idhifa won the agency’s backing to treat relapsed/refractory AML patients with an IDH2 mutation, becoming the first such drug for a group that represents between 8% and 19% of all AML patients, according to a release from Celgene. It’s also the first oral, targeted inhibitor for the mutation to win agency backing.
New hope HIV vaccine from J&J and partners passes early test
new early-stage results announced Monday, Johnson & Johnson and its partners hope they might have a winner.J&J touted the phase 1/2a study results early Monday, announcing that an investigational shot appeared to be well-tolerated and elicited HIV-1 antibody responses in all participants. The study tested a “mosaic” HIV vaccine in nearly 400 patients across the U.S, Rwanda, Uganda, South Africa and Thailand.
Keytruda missed its goal in a head and neck cancer trial
Merck & Co.’s Keytruda missed its goal in a head and neck cancer trial—a goal that its closest rival, Bristol-Myer Squibb’s Opdivo, met last year.The tables were turned last year, when Keytruda scored its win in previously untreated lung cancer patients and Opdivo didn’t.Both drugs are PD-1 checkpoint inhibitors, with lists of indications that are all but identical except in lung cancer. But a series of differing study outcomes, between these two meds and among others in the same class, highlight just how much drugmakers still don’t know about these big-selling—and groundbreaking—therapies.
Lexicon diabetes pill hits endpoint in another phase 3, teeing up regulatory filings by partner Sanofi
Lexicon Pharmaceuticals has posted upbeat data from another phase 3 trial of its Sanofi-partnered dual SGLT1 and SGLT2 inhibitor sotagliflozin. More patients in the treatment arm hit an established target for glycemic control than did in the control cohort, resulting in Lexicon chalking up its third phase 3 success for the diabetes tablet.
Sanofi and Regeneron’s Praluent safely smacks LDL in high-risk diabetics
Sanofi and Regeneron still have months to wait for final data from a key cardiovascular outcomes study of their PCSK9 therapy Praluent. But the pair now has results in hand suggesting the med can safely cut “bad” cholesterol in Type 2 diabetes patients at high risk of CV problems.On Sunday at the American Diabetes Association’s annual meeting, the companies unveiled two studies that fall under the Odyssey outcomes trial umbrella. In the first, dubbed Odyssey DM-Insulin, Praluent slashed low-density lipoprotein (LDL) cholesterol by 49% compared with placebo in insulin-treated Type 2 diabetes patients with both high cardiovascular risk and high levels of the so-called bad cholesterol not controlled by maximum tolerated doses of statins.
Roche’s Tecentriq fail its phase 3 trial in second-line bladder cancer
Roche’s Tecentriq wasn’t supposed to fail its phase 3 trial in second-line bladder cancer. But that’s what it just did—and the data shortfall not only endangers the drug’s conditional FDA approval, but could augur trouble ahead for other checkpoint inhibitors that followed Tecentriq into the field.
AstraZeneca immunotherapy wins first approval in bladder cancer
U.S. regulators have approved AstraZeneca’s key immunotherapy drug durvalumab as a treatment for bladder cancer, marking the first commercial green light for a product the company hopes will go on to sell billions of dollars.The approval, while expected, marks a milestone for the British company, which expects new cancer drugs to help revive its fortunes following patent losses on older blockbuster products like cholesterol pill Crestor and Nexium for heartburn.Bladder cancer itself is a relatively small initial market, where AstraZeneca is lagging behind rivals Bristol-Myers Squibb and Roche whose immunotherapies are already approved for the condition.
The FDA Just Approved One of the Most Expensive Drugs in the World
The Food and Drug Administration (FDA) on Thursday gave its green light to the medicine, BioMarin Pharmaceutical Inc.’s bmrn Brineura. It’s the first-ever drug approved for a form of Batten disease, a rare genetic disorder that ravages the nervous system and can cause symptoms ranging from seizures to trouble coordinating muscles to vision loss. It can affect both adults and children; Brineura is approved for kids who are at least three years old.
First New Drug for Liver Cancer in a Decade: Regorafenib
The US Food and Drug Administration (FDA) has expanded the indication for regorafenib (Stivarga, Bayer) to now include treatment for patients with hepatocellular carcinoma (HCC) who have previously been treated with the drug sorafenib (Nexavar, Bayer).Expansion of regorafenib’s indication marks the first FDA-approved treatment for a liver cancer in almost a decade.
Top 10 U.S. patent losses of 2017
Anticipated expirations for 2017 include Roche’s Rituxan, GSK’s Advair, Eli Lilly’s Humalog and Cialis, AstraZeneca’s Byetta, Pfizer’s Viagra and Merck’s Vytorin, according to the report. Together, the 2017 patent losses and associated sales declines will “continue to pressure growth” in the industry
Novartis Kickbacks : Hand over the info on those 79,000 events
A U.S. judge has ordered Novartis to do something it’s been trying for a year to avoid: Hand over documents on 79,236 educational events the company says it held with doctors. Federal prosecutors claim those events were shams. They call them “kickbacks” instead. The government alleges that Novartis invited the same doctors to speaker events over and over, treating them to lavish dinners at Nobu and Smith & Wollensky—and gatherings at Hooters—in return for prescribing more Novartis meds.
Greece’s corruption prosecutor quits, citing pressure over Novartis bribery probe
Novartis is embroiled in a soap opera in Greece, complete with bribery allegations and a suicide threat. Now the plot is thickening. The country’s chief corruption prosecutor, Eleni Raikou, has resigned—and she’s blaming the Swiss pharma giant’s legal issues for her decision.Raikou stepped down over the weekend, according to the Athens News Agency-Macedonian Press Agency (ANA-MPA), sending a letter to Greece’s Supreme Court claiming she was targeted by “unofficial power centres” over her investigation of Novartis, which started in early January. Her resignation followed a less-than-flattering article in a weekly newspaper, according to anonymous sources quoted by the wire service. In her resignation letter, she griped about a lack of “institutional protection,” the ANA-MPA reports.
New ovarian cancer drug niraparib (Zejula)won an FDA approval
Tesaro The company’s closely watched ovarian cancer drug niraparib—now dubbed Zejula—won an FDA nod Monday, months before its scheduled decision date.And not only that. Zejula won an approval that’s broader than the label on its head-to-head rival, Lynparza from AstraZeneca. It’s approved to treat all women with recurrent ovarian, fallopian tube or peritoneal cancer who’ve previously responded to platinum chemo, not just those who test positive for the BRCA genetic mutation.
The FDA has rejected AstraZeneca’s hyperkalemia drug ZS-9 for the second time in 12 months
The news marks a further blow for a program AstraZeneca saw giving it a sizable share of a $6 billion (€5.5 billion) market when it acquired the asset in its $2.7 billion buyout of ZS Pharma. Next to nothing has gone right for AstraZeneca and ZS-9 since then. The problems began in May when the FDA rejected the drug—which was already being reviewed at the time AstraZeneca bought ZS Pharma—on the basis of observations made by its inspectors during a preapproval assessment of the ZS-9 manufacturing facility. Ten months later, AstraZeneca is still being dogged by regulatory concerns about the production of ZS-9.
Sanofi plan to sell its its European generics unit
After losing out on two sizable deals, Sanofi CEO Olivier Brandicourt recently said his company wasn’t looking to make any big M&A moves right away. Instead, Sanofi might be looking to slim down by prepping the sale of its European generics unit, according to a new report.The French drugmaker wants to hire advisers by the end of this month and conduct an auction after the summer for a deal estimated to be worth about €2 billion ($2.1 billion), sources told Reuters.
Trump promises a ‘new system’ to lower U.S. drug prices
Donald Trump on Tuesday promised that he hasn’t abandoned his pledge to take action.Trump first tweeted Tuesday that “getting rid of state lines, which will promote competition, will be in phase 2 & 3 of healthcare rollout,” apparently referring to geographic restrictions on insurers—and filling in what he sees as a gap in the Obamacare repeal-and-replace effort.
FDA to accept EMA’s facility inspections in EU as its own
Both regulators reported that they have agreed to recognize inspections that each performs of human drug manufacturing facilities conducted in their respective territories on both sides of the Atlantic.
New Chemo Drug Eluting Beads for Liver Tumors Cleared in Europe
BTG, a company based in London, UK, won European CE Mark clearance for its DC Bead LUMI radiopaque drug-eluting bead. This is the first such device available in Europe.The beads can be loaded with either doxorubicin or irinotecan, commonly used chemo agents, and injected into tumors within the liver.
Novartis’ Zykadia gets a front-line boost in lung cancer race against Roche
Novartis’ Zykadia and Roche’s Alecensa are both gunning for front-line nods in ALK+ NSCLC.Novartis isn’t letting its crosstown rival get all the regulatory attention when it comes to ALK+ metastatic non-small cell lung cancer.On Thursday, it moved toward evening the score with nemesis Roche, winning an FDA priority review for cancer-fighter Zykadia as a first-line treatment for patients with the disease. It also picked up the agency’s breakthrough designation for first-line treatment of ALK+ NSCLC patients with brain metastases.It’s a step in the right direction for Zykadia, which is currently approved for patients who have already failed on Pfizer’s Xalkori. Last September, the Novartis med showed it could top standard chemo at improving progression-free survival in the front-line setting, hitting secondary endpoints in objective response rate and duration of response, too.
Patient death in phase 3 raises doubts about safety of Roche’s potential hemophilia blockbuster emicizumab
Roche has revealed that a patient died in a phase 3 hemophilia trial of bispecific antibody emicizumab. The trial investigator ruled the death was unrelated to emicizumab, but, with the event following on from other reports of similar serious adverse reactions, it has added to questions about the safety of the experimental regimen.
FDA clears 7SBio’s ‘virtually painless’ blood collection device
Seventh Sense Biosystems (7SBio) picked up an FDA nod for its “push-button” blood collection device, specifically to test the HbA1c levels in patients with diabetes and prediabetes. The company plans to add more assays for use with the device.
Sanofi reported fourth-quarter net income of $852.2 million.
The Paris-based company said it had net income of 33 cents per share. Earnings, adjusted for non-recurring costs, came to 67 cents per share.The results met Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was also for earnings of 67 cents per share.The drugmaker posted revenue of $9.56 billion in the period.For the year, the company reported profit of $5.21 billion, or $2.03 per share. Revenue was reported as $37.43 billion.Sanofi shares have fallen slightly since the beginning of the year. The stock has increased almost 3 percent in the last 12 months.
Pharma giant Pfizer opens new $50m Saudi manufacturing hub
Pfizer Saudi Limited says factory will produce a number of life-changing medicines for patients in Gulf kingdom , The Saudi subsidiary of pharmaceutical giant Pfizer has announced the opening of a new $50 million manufacturing facility in the Gulf kingdom.Pfizer Saudi Limited has launched its factory in King Abdullah Economic City (KAEC), and announced the start of manufacturing of a number of life-changing medicines for patients in Saudi Arabia.
Ionis, Novartis Ink Deal to Focus on Cardiovascular Treatments
Ionis Pharmaceuticals, Inc.IONS , along with its subsidiary Akcea Therapeutics, announced that the company has entered into an exclusive, worldwide collaboration agreement with Novartis AG NVS for the development and commercialization of two novel treatments, AKCEA-APO(a)-L and AKCEA-APOCIII-L, with the potential to treat cardiovascular disease
Sanofi beats Novo to launch with diabetes combo Soliqua, kicking off the market-share grab
Sanofi and Novo Nordisk may have tied in the regulatory race for their basal insulin/GLP-1 combo diabetes products. But it’s Sanofi that’s reached the market first, and it’s got a four-month lead to work with.The French drugmaker announced this week that it had rolled out Soliqua, a marriage of blockbuster insulin Lantus and GLP-1 med Adlyxin, at a list price of $127 for a 300-unit pen. Novo’s Xultophy, on the other hand—which, like Soliqua, won its regulatory green light on Nov. 21—won’t make it’s way to market until early May “following the training of our field sales force,” a company spokesman told FiercePharma.
Greece investigates Swiss pharma Novartis over bribery claims
Greece’s justice minister on Tuesday promised a “swift and thorough” investigation into suspected corruption by civil servants and Swiss pharmaceutical giant Novartis.Stavos Kontonis ordered an inquiry after “denunciations concerning bribes paid to functionaries by Novartis” appeared in the press, a ministerial statement said.”The judicial investigation will be swift and thorough,” it added.According to a judicial source, a preliminary investigation has been going on for two months and around 178 people in Greece have been questioned.The source said anti-corruption prosecutors had visited Novartis’s premises near Athens to gather evidence.The case gained attention in recent days following a suicide attempt in Athens on Sunday, New Year’s Day, by a Novartis manager.That attempt was thwarted by police and according to the judicial source, the manager was one of those questioned over corruption
Bad news for Sanofi Eli Lilly and Boehringer Ingelheim’s Lantus biosim Basaglar, scheduled to launch Thursday.
Sanofi’s Lantus is getting some unwanted competition in the basal insulin market, too.Eli Lilly and Boehringer Ingelheim were scheduled to launch Basaglar, a copy of the French drugmaker’s star product, in the U.S. on Thursday, as per an agreement from last September. And with the rollout, they now have a chance at nabbing a piece of Lantus’ €4.02 billion in U.S. sales.
Sanofi plans to cut 20% of its diabetes and cardiovascular salesforce in USA
Sanofi, under pressure from an underperforming diabetes business and slower-than-expected drug launches, plans to cut 20% of its diabetes and cardiovascular salesforce, which could amount to hundreds of jobs.The staff reductions are part of a larger shakeup for the diabetes and cardiovascular business, which Sanofi disclosed internally on Friday. “As a result of the new model, we did announce an approximate 20% staff reduction, including our sales force and some business support functions for this business unit,” spokeswoman Ashleigh Koss said via email.
Gilead Sciences has won approval for its next-gen hepatitis B treatment Gilead said that the FDA had approved Vemlidy, a once-daily treatment for adults with chronic hepatitis B virus (HBV) with compensated liver disease. The drug, however, comes with a black-box warning for risks. Gilead ($GILD) already has a hep B treatment, Viread, but said today that the new drug can be given at one-tenth the dose of Viread and so has better renal and bone laboratory safety parameters than its predecessor.
Bristol-Myers’ Opdivo nets the first PhIII gastric cancer win for checkpoint inhibitors Among chemo-intolerant patients or those who failed to respond to chemo, the checkpoint inhibitor topped placebo at extending overall survival, the company said. BMS’ partner, Japan’s Ono Pharmaceutical, conducted the trial in Japan, Korea and Taiwan.It’s a win for Opdivo, which is the first drug in its class to show a survival benefit in stomach cancer patients.
Reuters Pfizer considers cashing in on its consumer health biz Pfizer CEO Ian Read may have decided not to split the company up, but that doesn’t mean he isn’t looking at divesting units. Word is the company is considering doing something with its consumer health operations and that it could bring in $14 billion or more.
AstraZeneca’s top line got hit hard in Q3 much of the pain came from plummeting Crestor sales. But the British drugmaker had its underperformance in a couple of key therapy areas to blame, too.Product sales of $5.03 billion landed 14% below consensus estimates
Lawmakers suggest Lilly, Novo, Sanofi colluded on insulin prices Sen. Bernie Sanders, the firebrand of the drug price debate, has ratcheted up his attack on insulin prices, calling on the Justice Department and the FTC to investigate Eli Lilly, Novo Nordisk and Sanofi for possibly colluding on price increases. Earlier this week, Sanders took to Twitter to raise questions about insulin pricing over the years. Then on Thursday, he and Rep. Elijah Cummings, his frequent partner in attacks on drugmakers, sent a letter to the regulators. They pointed out that prices have escalated significantly over the years, but more importantly, they charged that the price increases have often happened at the same times.
GSK, Propeller ‘smart inhaler’ gets FDA green light Propeller Health scored an FDA clearance for the use of its digital respiratory disease management system with GlaxoSmithKline’s dry powder inhaler, Ellipta. The clearance comes after the duo teamed up on “smart inhaler” tech back in December 2015. Propeller Health’s sensor attaches to various inhalers to track when patients take their medication. Usage data is transmitted via Bluetooth to a smartphone app, where patients and physicians can see where, when and why patients use their inhalers. The sensor forms the base of Propeller’s digital therapy platform, which uses machine learning to help patients manage their condition
Sanofi’s vaccines pump up Q3 growth while other units trickle along Sanofi’s vaccines continue to be a spot of sunshine in the French drugmaker’s overall cloudy picture. In the third quarter, Sanofi Pasteur grew sales 14% over last year, besting all other units but the company’s rare-disease group, Genzyme.To notch the sales win, Sanofi Pasteur can thank early flu shipments to the U.S., execs said on a call with analysts, a tactic that rival GlaxoSmithKline cited in its own results for the period. Sanofi’s influenza vaccines were up 35% on the quarter to €989 million ($1.1 billion).
LEO Pharma and MorphoSys enter into strategic alliance to develop therapeutic antibodies in dermatology LEO Pharma and MorphoSys AG today announced that they have entered into a strategic alliance for the discovery and development of therapeutic antibodies for the treatment of skin diseases. The objective of the alliance is to identify novel, antibody-based therapeutics for unmet medical needs that will be valuable additions to both companies’ pipelines.
Valeant in talks to sell Salix stomach-drug unit in $10 billion deal to Takeda Pharmaceutical Valeant Pharmaceuticals International Inc. is in talks to sell its Salix gastrointestinal drugs business to Japan’s Takeda Pharmaceutical Co., according to a person familiar with the matter.The unit could go for as much as $10 billion and there is at least one other bidder interested, the Wall Street Journal reported earlier. The deal would include at least $8.5 billion in cash, the Journal said, plus future royalty payments.
FDA gives Roche’s Ventana PD-L1 assay approval in lung cancer treatment The FDA gave its approval to Roche for its Ventana PD-L1 assay to be used as a complementary diagnostic in conjunction with the company’s Tecentriq (atezolizumab) for the treatment of metastatic non-small cell lung cancer.
Tokyo-based Astellas announced plans Friday to acquire Ganymed Pharmaceuticals Astellas Pharma, which has its U.S. headquarters in Northbrook, has agreed to buy a German biopharmaceutical company in an effort to build on its cancer drug offerings. Ganymed has focused on developing a new class of cancer drugs designed to kill tumor cells without hurting healthy tissues.
Astellas opens regional HQ in Dubai ,Astellas Pharma Europe has announced the opening of a new regional office in Dubai to support the company’s growing business operations in the Middle East, North and Sub-Saharan Africa (Mena/SSA).
New regional HQ for Eli Lilly in Dubai Healthcare City Dr. Amin Hussain Al Amiri, Assistant Undersecretary for Medical Practice and License Sector at the UAE Ministry of Health, has inaugurated Eli Lilly and Company’s new regional headquarters for Turkey, Middle East, Africa, Russia and the CIS (TMEA-CIS) in Dubai Healthcare City, UAE.Lilly, the world’s tenth largest pharmaceutical company, will manage its operations across more than 70 markets from its new base in Dubai.
J&J gain the rights to sell Rhinocort Aqua nasal spray outside of the US from AstraZeneca AstraZeneca have completed a third sell off in the course of one week by divesting rights to Rhinocort Aqua outside the US. The deal, which will be completed for $330 million, sees Johnson & Johnson affiliate Cilag GmbH International gain the rights to sell the nasal spray outside of the US.
Merck’s Keytruda posts 24% response rate in bladder cancer study Merck is chasing rivals Roche and Bristol-Myers Squibb in bladder cancer, but now, it has some new data in hand showing its checkpoint inhibitor, Keytruda, could combat the disease as an up-front treatment for some patients.Data on the first 100 patients in the Phase II Keynote-052 study–which enrolled 374 previously untreated bladder-cancer sufferers ineligible for cisplatin chemo–showed that 24% responded to the therapy. The patients’ tumors shrank, regardless of their PD-L1 biomarker status, Merck said Saturday at the ESMO 2016 Congress. And 6% showed complete responses, exhibiting no detectable cancer after treatment.
Novartis’ Ibrance challenger cuts breast cancer progression risk by 44% The combination of LEE011–also known as ribociclib–and Femara (letrozole) cut the risk of disease progression or death by 44% over solo Femara in women with cancers classified as hormone receptor positive and human epidermal growth factor receptor-2 negative (HR+/HER2-), Novartis said at the ESMO 2016 Congress.
Xarelto may cause more serious bleeding than BI’s Pradaxa, real-world study shows Boehringer Ingelheim may have one such advantage for its Pradaxa (dabigatran) over market leader Xarelto (rivaroxaban), thanks to a new observational study.Patients on Xarelto–marketed by Johnson & Johnson and Bayer–may be more likely to experience serious bleeding events than patients taking Pradaxa, according to a study published this week in JAMA Internal Medicine.
Hep C drugs are getting a black-box warning from the FDA the agency said it would bestow its most serious label warning on a group of direct-acting antivirals (DAA), comprising Gilead’s Harvoni, Sovaldi and Epclusa, AbbVie’s Viekira Pak and Technivie, Merck’s Zepatier, Bristol-Myers Squibb’s Daklinza and Johnson & Johnson’s Olysio.The reason? The meds increase the risk that a hep B infection could come roaring back in current or previous hep B patients.
J&J’s next-gen psoriasis med tops Humira in head-to-head study The New Jersey drugmaker announced Saturday that its prospect had beaten out AbbVie best-seller Humira in a Phase III trial, recording a higher proportion at Week 16 of patients achieving cleared or minimal disease, J&J said.
Novartis late-breaking data show Cosentyx delivers high and long-lasting skin clearance over 4 years for psoriasis patients
Amjevita, a Biosimilar to Humira, Wins FDA Approval Amgen’s Amjevita (adalimumab-atto) is the first adalimumab (Humira) biosimilar approved by the U.S. Food and Drug Administration (FDA)
FDA Clears Yosprala to Lower Cardiovascular Risk Once-daily Yosprala (aspirin and omeprazole) from Aralez Pharmaceuticals is now FDA approved for patients who require aspirin for secondary prevention of heart attack or stroke and who are at risk of developing gastric (stomach) ulcers due to aspirin use
FDA Approves Bayer’s Kyleena (Levonorgestrel-Releasing Intrauterine System) for Prevention of Pregnancy for up to Five Years from bayer
KVK Tech Announces FDA-Approval of Lomaira (phentermine hydrochloride USP) for Weight Reduction
Novel Novartis malaria compound shows potential to be effective against infections resistant to all currently available antimalarial drugs
Novartis BAF312 reduces the risk of disability progression in pivotal phase III study in secondary progressive MS patients ,- Novartis today announced positive results of the Phase III EXPAND study showing that oral once-daily BAF312 (siponimod) significantly reduced the risk of disability progression compared with placebo in people with secondary progressive multiple sclerosis
Merck and Pfizer Announce Investigational Ertugliflozin Met Primary Endpoint of A1C Reduction When Added to Sitagliptin and Metformin in People with Type 2 Diabetes
Amgen’sKyprolis has failed against Takeda’s Velcade in a Phase III trial in patients newly diagnosed with multiple myeloma. The data undermine Amgen’s attempts to justify the $10.4 billion it paid for Onyx Pharmaceuticals by establishing Kyprolis as a cornerstone of first-line multiple myeloma treatment.
Emma Walmsley will be the new CEO at GSK GlaxoSmithKline has named its next CEO, and it’s breaking new ground in the process. Emma Walmsley, who heads up GSK’s consumer health business, will become the first woman to take the helm at a Big Pharma company