Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.
Evolocumab holds the FDA's first filed biologics license application for the class.
PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.
Human testing of GSK's Ebola virus starts next week, menopause is a costly healthcare concern, and a small conversation with pharmacists may have a big impact.
The US District Court for Maryland granted Hospira a temporary restraining order (TRO) against FDA, after the agency determined that potential generic competitors of the company's injectable sedation drug Precedex could be approved.
Promacta was previously indicated for chronic immune thrombocytopenia.
Allergan sets a shareholder voting date, Novo describes the types of acquisitions it will consider, and the AstraZeneca-Pfizer talks can now reopen.
The new SGLT-2 inhibitor is on shelves less than a month after FDA approval.
The Pharmaceutical Research and Manufacturers of America (PhRMA) says a California federal court should dismiss a whistleblower's False Claims Act suit against three drug companies on First Amendment grounds
Merck and Pfizer pursue new pembrolizumab research, black box warnings are linked to fewer court visits, and the WHO says it needs $430M to fight Ebola.
FDA says that it is seeing and receiving consumer complaints about products sold online that claim to either prevent the Ebola virus or treat it.
Roche has beat out rumored competitors GlaxoSmithKline and Sanofi in a run-off to acquire California biotech InterMune.
Roche backs away from Chugai but embraces InterMune, Merck rumored on track to score first PD-1 approval, a new Ebola strain may have surfaced and JNJ scoops up experimental anti-TNF.
Two new indications give Eliquis more juice, a new rule is making hydrocodone harder to get and the ALS Ice Bucket Challenge highlights a controversial aspects of drug discovery and development.
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.
An Ebola survivor is set to leave Emory University Hospital, but the cause of the cure is uncertain, the FDA has approved a new type 1 diabetes test, and the latest in the Allergan-Salix battle.
The oral medication Cerdelga joins Cerezyme in its Gaucher disease arsenal. Sanofi expects the drug will be priced "on par" with Cerezyme, which goes for around $300,000 a year in the US.
Phase-III tests indicate patients may be able to switch from injectable enzyme-replacement therapies, like Fabrazyme, to the firm's oral drug.
Novartis explores the virtual care space, a court has dismissed a lawsuit against IPAB, Doctors Without Borders calls the Ebola outbreak "a complete disaster" and Pfizer becomes the first pharma company to pair with the Crohn's and Colitis Foundation of America.
Sanofi's patent lawsuit triggered the tentative approval of the Lilly-BI Lantus competitor.
The refresh launched soon after the company encouraged investors to take a long view of GSK as the firm posted weak respiratory numbers.
Lilly/BI receives tentative approval for insulin biosimilar; Ebola death rate hits new high; LaMattina sounds off on Pfizer's oncology efforts; art therapy becoming the norm in hospitals.
Plegridy is the only pegylated beta-interferon drug approved for relapsing multiple sclerosis.
FDA feedback will influence a new clinical trial design, but the regulator's recent reaction was a bit of a surprise.
Roche is rumored to be stalking a Chugai acquisition, Pfizer has hit its palbociclib filing deadline and Supernus scored a Fast Track designation for its experimental ADHD drug.
UK drug-cost watchdog backs Sovaldi, Achillion touts HCV interim results, Avastin's latest cancer indication, Ebola outbreak worsens, COPD drug gets panel nod, and study links quick reviews and black-box warnings.
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.
It could also eat into Merck's Pneumovax sales.
Merck insomnia aid nabs FDA approval, AZ's severe asthma drug advances to Phase III, Specialty med costs expected to comprise more and more Medicare Part D spending.
Not long after acquiring Shire to add to its orphan-drug portfolio, the drugmaker scored an orphan designation from both FDA and EMA last week.
African-American women had the highest risk of being diagnosed with diabetes—55%. Hispanic men and women were close behind, carrying a 50% risk of being diagnosed with diabetes.
Robin Williams's suicide highlights a trend among the Boomer generation, and governments resurrect a little-used strategy to contain Ebola.
The Sanofi and GSK marketing virtuoso has taken over as CEO and president at Synta Pharmaceuticals.
Half-measures, like diabetes educational materials without a part B, fared poorly.
The World Health Organization rules on untested Ebola drugs, while Mapp Biopharma has already run out of its experimental antibody.
After weeks of speculation as to whether MannKind would find a marketing partner for its inhalable insulin, the drugmaker said today that Sanofi would acquire global licensing rights to the drug for $925 million.
The company is seeking a diabetic retinopathy indication.
Britain's National Institute for Health and Care Excellence has followed through on its Kadcyla objections and has said Roche's breast cancer drug will remain off the National Health Services formulary because it is too expensive.
The drugmaker will dole out $35 million in a deal with 41 state attorneys general after a New York County Supreme Court judge said Wyeth allegedly promoted the immuno-suppressive drug improperly.
The drugmaker is collaborating with Charleston Laboratories in the development and commercialization of hydrocodone products. The deal means Daiichi Sankyo now has two pipeline opiates.
The painkiller's marketer will look to partner with another manufacturer to better target primary care physicians, and will also reexamine its sales territories.
Approved in May 2013, the cancer drug earned $57 million in the second quarter, and the firm expects it will hit annual sales of $1.31 billion.
Better late than never: Although Lilly and BI's Jardiance is the third SGLT-2 inhibitor to hit the U.S. market this year, it may also be the most successful.
The $250 million cash deal includes an additional $200 million in milestone payments.
Blood-cancer drug Kyprolis outperformed standard treatment in a late-stage trial testing the drug in patients with multiple myeloma, said Amgen.
Arena's recent quarter shows weight-loss drug Belviq is on the rise. It follows a DTC push and the recent addition of reps by co-marketer Eisai.
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.
A 2005-to-2010 survey shows diabetics 65-and-up juggle at least four co-morbid conditions and five medications for them.
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.
Physician and industry trade groups are asking CMS to explain how context will be provided to the general public around the dollar sums drugmakers ascribe to doctors for things like meals, travel, gifts, consulting and research
Patent losses and lost co-promotion agreements put a dent in sales.
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 company attributed part of the Eliquis boost to the BMS-Pfizer DTC and education efforts.
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.
Executives urge analysts to focus on the company's long-term potential.
The Speeding Access to Already Approved Pharmaceuticals Act of 2014 would require FDA to expedite the review of pharmaceuticals that are already approved by the European Union
Sales reps are experiencing even more limited physician access, according to a report by Chicago consultancy ZS Associates.
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.
Less-frequent dosing and competitive pricing could spur a shift in market share among products that treat the hereditary blood disorder.
Parent Project Muscular Dystrophy (PPMD) and allied stakeholders recently gave FDA the first patient advocacy-initiated guidance for a rare disease to help accelerate development and review of potential therapies for Duchenne muscular dystrophy.
The rate of decrease in industry's budget for continuing medical education (CME) slowed last year.
Researchers at the Brigham and Women's Hospital found that continuity in color and shape have a significant impact on whether patients stick with a prescription regimen.
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.
Shire and AbbVie's courtship has entered round five. A deal would offer AbbVie tax relief, and possibly make it an acquisition target.
In the latest chapter in the Sovaldi pricing saga, Senators Ron Wyden and Charles Grassley urge Gilead to clarify Sovaldi sticker shock.
Bristol-Myers Squibb is moving forward with its FDA filing of PD-1 Opdivo (formerly known as nivolumab) for patients with advanced melanoma who have been previously treated with the BMS drug Yervoy.
Salix Pharmaceuticals joins the tax-inversion migration by purchasing Cosmo Technologies.
The FDA says the OTC remedy maker's online behavior—including Liking customer Facebook posts—has put the company's drugs in unapproved drug territory.
Two weeks after its $46-billion bid was shot down, AbbVie has revised its offer in hopes of opening up negotiations with Shire.
The drugmaker received a notice from the advertising watchdog over promotion of hep. B treatment Viread in a sponsored link on Google AdWords.
Purdue Pharma expects the FDA to vote yea or nay on the drug by October.
Patients want to do more with mobile and see doctors less. Two studies outline the types of digital interventions patients are interested in.
In what amounts to a sudden about face, CMS wants to delete the Sunshine rule's exclusion for continuing medical education.
The solution: talk to patients.
The consumer-facing edition of The Merck Manual Go-To Home Guide for Symptoms is being released as a mobile app.
The Centers of Disease Control reports that prescribers wrote enough painkiller prescriptions to give one bottle to every adult in the US in 2012.
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.
Researchers from Boston Children's Hospital, Harvard Medical School and Brigham and Women's Hospital are offering a bit of internet advice for the Food and Drug Administration: do more.
The FDA approved the inhaled insulin last week.
Following two comprehensive rounds of scoring by more than 100 independent industry judges, the results are in for the MM&M Awards 2014. Here are the five finalists for each of the 31 categories
IMS is offering $520 million cash to add Cegedim's CRM and strategic data business. Cegedim says it will use the money to pay down debt.
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.
EvaluatePharma's World Preview 2014 has pharma soaring to new lucrative heights in six years' time, buoyed by biologics and a formidable pipeline.
Celebrity endorsement, co-pay cards and online edutainment are some of the ways marketers are dueling for attention in the prescription omega-3 space.
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.
Four months after announcing a review of low-testosterone treatments for risk of heart attack and stroke, the regulator expanded the classes' warning label to include a general risk of blood clots.
Platform lets pharma firms mine big data, and monitor whether millions spent on ad campaigns or medical education are having the desired effect
An Alzheimer's Association survey finds 59% think the degenerative disease is just part of aging.
Researchers are increasingly using social media to recruit patients, albeit oftentimes in an arms-length manner.
Guidance on promoting products in 140 characters and correcting misinformation serves as a guarded green light, says one observer.
Researchers at Montreal's McGill University survey the explosion in prescription painkiller use and abuse.
The American Diabetes Association has established an across-the-board recommendation that children 18 and younger should keep A1C levels at 7.5% or lower.
An early look at healthcare reforms impact indicates that allowing children to stay on a parent's healthcare plan until they turned 26 did not translate into higher use of medical care, but did lower out-of-pocket healthcare costs for the 19-25 age group.