The bill proposes fining branded drugmakers for not complying.
The Chesterbrook, PA, drug manufacturer announced Monday Endo's unsolicited $2.2-billion bid undervalued the company.
GSK releases polio-infected water into Lasne River in Belgium; House reps Burgess and Schwartz introduce CME exemption bill for Sunshine Act; NIH and FDA announce plan to create facebook-esque catalogue of oral-drugs.
Lilly's weekly GLP-1 shot is approved, BI expands its lung-cancer portfolio, GSK's China investigation closes, NY proposed Sovaldi triage and India imposed price limits on 36 new medicines.
The drugstore chain has lowered its forecast, and generics are just one reason.
Plans to unwind the Suffern, NY, site move forward this winter.
Merck unveiled the DPP-IV clinical trial results at the European Association for the Study of Diabetes Annual meeting Thursday.
Endo's timing also comes as Auxilium has committed to reorganizing and merging with Canada's QLT.
The Department of Justice is looking into Medicaid pricing.
Switzerland is pushing Roche to lower its prices on Perjeta
HealthKit off to a bumpy start; Endo offers $2.2 billion for Auxilium; Gilead advanced pancreatic cancer drug fails in trial.
Keytruda was the first of the new PD-1 class of immuno-oncology drugs to reach the US, but Bristol-Myers Squibb and Ono could run away with the competition, according to one analyst.
Analysts do not expect odanacatib to be a major earner.
The designation is for diabetic retinopathy for patients with diabetic macular edema.
Phase-III results of the AbbVie-Biogen Idec experimental multiple sclerosis shot Zinbryta (daclizumab) indicate the drug bests Avonex (interferon beta-1a) on some measures among relapse-remitting MS patients.
Takeda's Director of Obesity Marketing Katie Andino told MM&M in a phone interview that the drugmaker will be taking a unique approach to woo patients, physicians and payers.
Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.
With its label extended to the pre-chemo setting, the prostate cancer drug is poised to reach a new group of urologists, and could upend J&J's Zytiga.
The plan is to bring in-house products to the market as well as through acquisitions.
The company said in a statement that the findings indicated the Spiriva-Striverdi combination treatment could help patients "return to a more independent life."
Lilly's long-acting insulin showed it's more effective in type 1 diabetics than Lantus, but concerns about its overall profile persist.
Bloomberg reports that India's Wockhardt has become an M&A target.
Pfizer will sell two Novartis drugs in the UK.
Sales reps are among the pinked-slipped in Spain.
The new PCSK9 class of cholesterol-lowering antibodies continues to look promising, but many doctors—particularly PCPs—have never even heard of the experimental drugs.
The FDA froze the clinical trial of anti-Fzd7 vantictumab in July over concern about "bone-related adverse events."
Baylor College of Medicine researchers have found that an estrogen replacement suppressed binge-eating behavior among lab mice.
Key opinion leaders indicate they are ready to embrace Novartis's experimental heart failure medication LCZ696. Such a move could upend heart failure treatment protocols.
Phase-III tests indicate Lilly's experimental treatment bests Amgen's for moderate-to-severe plaque psoriasis.
The FDA has approved Arnuity Ellipta for asthma.
Phase-III tests indicate patients may be able to switch from injectable enzyme-replacement therapies, like Fabrazyme, to the firm's oral drug.
AstraZeneca announced the end of the investigation Tuesday.
Amgen now hopes a separate study will be enough to support the drug's advancement to a second-line therapy, but the lackluster results may impinge on its EU filing schedule.
GlaxoSmithKline, Actelion, Sanofi and Roche are said to be among a host of suitors.
Layoffs are reported to be in the offing.
Blood-cancer drug Kyprolis outperformed standard treatment in a late-stage trial testing the drug in patients with multiple myeloma, said Amgen.
Sanofi and partner Regeneron attached a $67.5-million priority review voucher to their experimental cholesterol drug alirocumab, making for a tighter race with Amgen.
The company is calling the move a withdrawal, as opposed to a recall.
The meningitis and encephalitis medications earned a combined $300 million last year.
The Wall Street Journal reports that patients are sharing a plethora of information about their clinical trial experiences, from how to get picked, to how to figure out who is in a control group.
AstraZeneca has made an $875-million move to beef up its respiratory pipeline by making Almirall's lineup its own.
The majority of the layoffs will be in the US.
Patent losses and lost co-promotion agreements put a dent in sales.
The company refutes a Financial Times rumor that one was happening soonish.
A study indicates they may do little to reduce the risk of stroke or heart attack.
Afrezza was heralded as one of the most innovative diabetes products of the last decade. So, why hasn't MannKind set a firm launch date for the product?
The drug did not hit its Phase III primary target of improving progression-free survival.
Disclosed in its earnings report yesterday, Gilead may have a card up its sleeve to counter Merck's experimental hep. C combo regimen.
Biogen Idec is seeing strong sales for blockbuster MS drug Tecfidera, especially overseas where it's beginning to catch fire this summer.
A $225-million deal with US biotech ArmaGen gives Shire worldwide commercialization rights to an experimental enzyme replacement therapy.
Executives urge analysts to focus on the company's long-term potential.
HPV testing provides an edge over Pap screenings when it comes to detecting cervical cancer risk.
CEO Severin Schwan tells Reuters that the Swiss firm will be looking for small acquisitions and partnerships.
Allergan's second-quarter earnings, and a new round of cuts, are now part of the Botox maker's record as it seeks to remain independent.
The deal includes a $1.6-billion fee if AbbVie tries to walk away.
An international AIDS conference this weekend kicked off a new battle in the war against hepatitis C: demonstrating high cure rates in those who are co-infected.
AbbVie, in the latest example of a US drugmaker seeking to lower its tax rate, said today that it's buying Dublin-based Shire for $54 billion.
Less-frequent dosing and competitive pricing could spur a shift in market share among products that treat the hereditary blood disorder.
Hepatitis C medication Olysio was a star, but the company cautions competition is coming.
The FDA granted Priority Review for consideration of Avastin for some cervical-cancer patients.
An advocacy group alleges that Shire's decision to ignore the US Fabry disease market was the result of a backroom deal with Sanofi.
Novartis and the nonprofit Banner Alzheimer's Institutes are testing a theory that treating healthy patients could prevent or delay Alzheimer's disease.
Shire and AbbVie's courtship has entered round five. A deal would offer AbbVie tax relief, and possibly make it an acquisition target.
Abbott and Mylan are setting up a generics business. The all-stock deal will give some branded generics a new home and offer Abbott a tax benefit that will increase over time.
Cyramza patients had more favorable overall survival rates than placebo patients, but the differences were not statistically significant.
In the latest chapter in the Sovaldi pricing saga, Senators Ron Wyden and Charles Grassley urge Gilead to clarify Sovaldi sticker shock.
Allergan will implement company-wide cost-cutting maneuvers, Bloomberg reports, to keep Valeant at bay.
Two weeks after its $46-billion bid was shot down, AbbVie has revised its offer in hopes of opening up negotiations with Shire.
The companies will develop Lilly's glucokinase activator LY2608204.
It's the generics maker's second recall of 2014.
The Wall Street Journal notes that a new study on testosterone therapy has some weaknesses, including its sole focus on men who received injections—leaving out pills, patches and gels.
Editorial says risk is small, researchers say it could be clinically relevant.
Zogenix is working on a less easily abused formulation of its controversial prescription painkiller.
French lawmakers have the chance to vote for off-label use of Avastin, potentially eating into the turf of higher-priced Lucentis.
Boehringer Ingelheim's experimental idiopathic pulmonary fibrosis treatment nintedanib is also an orphan drug.
The Indian Pharmaceutical Alliance makes a bid for legislators' attention.
The American College of Physicians says most women do not need an annual pelvic exam. The American College of Obstetrics and Gynecologists disagrees.
Allergan's latest pipeline news was a mix of the good and the bad. The good: a potential Lucentis competitor is progressing. The bad: migraine medication Semprana has stalled.
The FDA approved the inhaled insulin last week.
The regulator wants men to be part of breast cancer clinical trials.
Novartis no longer has a lock on the Diovan market: the FDA approved Ranbaxy's generic, which will be made in the US.
Pennsylvania drugmaker Auxilium will merge with Vancouver-based biotech QLT to lower its corporate tax rate.
An FDA advisory panel voted 11-2 against an accelerated approval for AstraZeneca's experimental PARP inihibitor. The panel recommends getting more data before giving the drug the all-clear.
The firm ended the Phase III trial for its ballyhooed immunotherapy, which showed superior survival compared to chemo in advanced melanoma.
Certain claims of the patents protecting the ADHD drug were both infringed and valid, a court ruled, giving Shire a boost as it contends with a takeover bid by AbbVie.
The firm said it expects to more than double its revenue within the decade, as the surging incidence of diabetes expands demand for its products.
An experimental Gelesis weight-loss drug seeks the middle ground between surgery and appetite suppressants.
Phase III results showing improved lung function among cystic fibrosis patients using a combination of Kalydeco and lumacaftor means drugmaker Vertex is filing the two-part drug for FDA approval during the fourth quarter.
Dublin-based Shire is urging shareholders to back independence and ignore AbbVie's $46.4 billion bid.
BI says there is no unmet need for faldaprevir.
GlaxoSmithKline dismissed a marketer over its approach to clinical trial recruiting.
Gene mutations lead researchers to rethink ways to protect the heart.
Researchers are increasingly using social media to recruit patients, albeit oftentimes in an arms-length manner.
The companies resubmitted SGLT2 inihibitor empagliflozen for FDA review. The EC approved the drug in May.
The drugmaker is pulling its US marketing application for the anemia drug.
The deal makes Medtronic the most recent company to seek out lower tax rates.
The drugmaker has told global regulators it failed to share 10,000 reported cases of side effects for a variety of its drugs.
Patients taking a high-dose form of Novo Nordisk diabetes drug Victoza saw an average weight loss of 5.9% of their body weight, data from a study show.
CFO Frank D'Amelio told an investors conference AstraZeneca wanted more money.
CEO David Pyott told Modern Healthcare that acquisition fallout would have probably included a pinched R&D budget and higher product prices.
Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.