Complete data sets have prompted researchers to say Tamilflu and Relenza fail at their key reason for being: preventing flu pandemics.
Phase-II results indicate Merck's all-in-one HCV oral could put pressure on Gilead.
The FDA issued an official halt, five days after Halozyme stopped the Phase-II trial because of patient stroke information.
The drugmaker is accused of burying cancer risks associated with the diabetes medication.
The regulator has put off the inhaled insulin's PDUFA date by three months.
Phase-III results prompted the drugmaker to pursue a third-quarter filing.
The announcement will create the fifth largest generics drug maker, reports Reuters.
The Swiss drugmaker has scooped up Oryzon's experimental acute myeloid leukemia treatment and private Massachusetts diagnostics firm IQuum.
WSJ's sources say allegations of misconduct are similar to those leveled against the company in China.
The GSK-Pfizer-Shionogi joint venture said it will add HIV med Tivicay to a United Nations patent pool, cutting its price for developing countries and granting access for generics firms.
The drugmaker is ceasing a trial called MAGRIT after it was unable to identify patients who could benefit from MAGE-A3.
The FDA has issued draft guidance that funds FDA inspection of some drug compounders.
The Israel-based drugmaker will try to extend the MS treatment's patent life until September 2015.
A court granted Lilly six more years of patent protection for the almost $3-billion-dollar-a-year cancer drug.
At a hearing today, Public Citizen and the generics industry are sounding off on an FDA proposal that would allow generics firms to update labels, regardless of whether the brand has or hasn't.
The FDA has approved a 24-hour version of Pfizer's heartburn medication.
The Carlyle Group has picked up Johnson & Johnson's Ortho Diagnostics for $4B.
The Bay State is saying no to the controversial prescription painkiller.
The Thousand Oaks, Calif. company says its cholesterol-lowering antibody hit its clinical trial endpoint among rare disease patients.
A rival's late-stage trial results suggest the pain med may have a short market life. The key: an FDA division head's documented willingness to overturn the approval should another pain option surface.
Analysts indicate the earlier-than-expected patent loss will not be a significant upset to Pfizer's present. The drugmaker plans to appeal the decision.
Bayer and Amgen's Onyx subsidiary announce an oncology drug failed a Phase-III trial goal among liver cancer patients.
Biogen Idec and Eisai said they will collaborate on and co-market two of Eisai's clinical candidates for Alzheimer's disease.
Kynamro's slow start, coupled with competition, has prompted Sanofi to add sales reps.
Bayer bought China-based Dihon Pharmaceutical Group, which specializes in traditional Chinese medicine consumer goods.
The drugmaker says the voluntary measure was out of an abundance of caution.
The agency says is it time to update the onerous decades-old review process.
Bloomberg reports that Teva has sparked interest as a takeover target.
Germany's price transparency requirement has the industry worried other markets will demand lower prices.
The drugmaker, hitherto known for its generic expertise, says the purchase could mean that half its future revenue will come from branded, specialty drugs.
Merck announced this week that its insulin glargine biosimilar, being developed with Samsung and Biogen Idec, would soon enter Phase-III trials.
The CEO told Leerink analysts the pharma business needs better margins, not unfettered R&D budgets.
Driven by a number of high-profile buys in 2013, pharma saw a return to investment through acquisition after a 2012 dip.
The new manufacturing site will be its first in Asia.
A panel is meeting February 10 to discuss revoking the OTC status of some medications.
The suit stalls Eli Lilly's biosimilar version of insulin glargine.
168 employees will be pink-slipped this quarter.
Amgen 2013 revenues increased by 17% from 2012 to $18.7 billion, the company reported, but it faces headwinds in 2014 for older meds.
Taken to new heights on the launch of MS blockbuster Tecfidera, the drug maker has raised its 2014 forecast.
Generics took a $2.2-billion bite out of sales, but growth products like Gilenya helped to minimize the impact.
The news follows company statements that China is not business friendly.
Prescription data shows Gilead's Sovaldi is winning prescriptions at a faster rate than Vertex's Incivek did at launch.
The company will be beefing up support of Sandoz, its generics division.
The latest IMS report shows that 50% of the top 50 pharma companies are not on social media. Executive Director Murray Aitken tells MM&M it is to pharma's detriment.
Analyst Seamus Fernandez, of Leerink Partners, says the drugmaker is set to be a considerable immuno-oncology and respiratory presence.
Herve Hoppenot changed jobs overnight.
The company bought rights to a Phase-II drug for recurrent migraine headaches.
The drugmaker announced Friday that the DOJ wants documents regarding sales and marketing of Juxtapid, its drug for an ultra-rare lipid disorder.
An insider says Merck may be up for trading its OTC business for Novartis's animal health business, but the benefits for either side may be better on paper.
Erez Vigodman will be Teva's president and CEO as of February 11.
Generics accounted for almost 75% of dispensed drugs in 2012, according to CMS researchers.
CMS is proposing a rule that could change how antidepressants get on Medicare Part D formularies.
Cambridge, MA-based Epizyme claimed $29 million in milestone payments from the two drugmakers.
The company's guidance aligns with expectations that 2014 will be a nail-biter.
Two months after it was pulled from the US market, Iclusig is returning with a narrower approval.
The $2.9 billion deal means Bayer owns prostate cancer drug Xofigo in full.
The American College of Cardiology is contributing its Pinnacle registry to identify clinical trial patients.
BMS is giving up its stake of the AstraZeneca diabetes joint venture for $2.7 billion up front, and future milestone payments.
Teva said a settlement will allow it to sell a copy of the blockbuster ED pill prior to the official LOE.
Biogen Idec and JV partner Samsung are going into the biosimilars business.
The FDA's Center for Drug Evaluation and Research released a preliminary year-in-review report that says the agency has cleared 26 new molecular entities this year.
Vaccine LU AF20513 is the their third Alzheimer's collaboration.
The company released two financial scenarios. The key is generic Copaxone.
Covidien is buying ingestible-camera company Given Imaging.
The drug is priced at $28,000 a month, before add-ons like ribavirin and (possibly) interferon.
The drug failed to hit its Phase III targets.
Novo's global diabetes study finds that only 29% of polled patients were asked what they thought about prescribed regimens.
Chronic disease patients seek online support and information, and show little love for branded websites.
Forest's cost-savings initiative is aimed at reducing operating expenses by $500 million, while Eisai said it's cutting 130 positions in the US and Europe.
Spectrum DNA says its genetic services are at the ready, even if 23andMe's are not.
The leukemia drug is staying on the market, but for a more restricted patient population.
The drugmaker says interim trial data meets FDA review requirements and is hoping for June 2014 approval.
Actavis shrinks its staff by 30%, and Bayer reduces its California footprint.
The agency's bad-ad warning letter calls the new violations "particularly troubling."
The patient population is small, at around 3,000, but the expected price tag is $330,000 a year.
Early clinical trial results indicate 81% of advanced melanoma patients survived for one year.
The catch is the difference between sales and revenues. Generics will continue to be a force, and small-audience drugs will become increasingly important.
Known as Breo Ellipta in the US, GlaxoSmithKline's Relvar Ellipta was approved by the EMA for asthma and COPD. The overall market is expected to continue to grow, but an NIH study indicates more patient conversations need to happen.
The US-only recall amounts to less than 1% of the company's inventory.
The current number is reported to hover around $4 billion.
The company says it will cut staff and costs, focus on big accounts and try to keep sales reps from leaving.
An investigational cardiovascular heart drug failed to reduce the risk of heart attack or stroke, a miss which some on Wall Street say raises questions about the drugmaker's ability to deliver in late-stage trials.
The company announced the layoffs Friday.
The FDA's Bad Ad group says the drugmaker misbranded its cholesterol drug during interviews on CNBC.
The company's pursuit of a tighter research focus follows a path very much like that of its peers.
A poll by consulting firm QPharma indicates doctors are in the dark about what needs to be reported and what will be revealed.
The drugmaker says 20 jobs, or 17% of its workforce, will be gone by the end of the year.
The "New Endo" will be one company on the outside, two on the inside.
The news is part of an ongoing reorg by the Swiss firm that is rumored to include selling off its animal health business.
A 15% increase in sales came on the back of HIV franchise meds Stribild and Complera/Eviplera.
Generic giant Teva refuted allegations that the CEO, Jeremy Levin, and the board of directors were at odds over the company's cost-saving maneuvers.
The company's hep. C drug Incivek peaked in 2011. Competition and pipeline drugs have forced the company to regroup.
The prostate cancer drug company is reportedly seeking a buyer to turn things around.
Based on its first three months on market, Tecfidera is one launch that's living up to its hype.
A court refuses to compel a government agency to schedule the firm's epilepsy drug, as the med's patent clock ticks.
The company says it is moving its Januvia sales pitch from defending market share to expanding it.
Vyvanse was one of six drugs with double-digit revenue increases, propelling sales of the specialty drugmaker Shire up 13% for the quarter.
A roundup of firms' quarterly performance culled from sources around the web.
Amid talk of cost containment, Lilly said it's also enjoying nice returns from some of its older diabetes drugs.
Word came of Breakthrough Designation for an HCV hopeful, a day after a hiccup in a heart drug trial.