FDA panel votes overwhelmingly against Low-T drugs; Stenda approved for fast-acting ED treatment; and Bayer hones life-sci focus, spins off material sciences business.
A mélange of new treatments awaiting approval and a lack of patient support are driving down drug utilization for Gilead's HCV blockbuster, according to a new study.
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.
NY's attorney general alleges that a formulation switch is an attempt to create monopoly.
Allergan inches closer to Valeant takeover; Mylan trials underway for Lantus biosimilar and generic Advair; FDA advisers to make decision tomorrow on whether testosterone products are being prescribed correctly and if the drugs' label merits change.
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.
The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.
Hires and promotions for manufacturers, regulatory and agencies
Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.
Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.
An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are expected to ship in 2015.
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.
Researchers using an experimental test have discovered that the 50% of surveyed diabetics may also have undetected heart muscle damage.
The plan is to bring in-house products to the market as well as through acquisitions.
Healthcare workers seek out health-related information on their own time, and through internet connections other than ones offered by their employers.
The first-in-class PD-1 was approved only last week.
EU grants Lilly/BI Lantus biosimilar approval; FDA approves Contrave weight-loss pill; Republicans take increased NIH funding off the table in Medical Innovation Act.
A series of CME initiatives, funded by Mallinckrodt, is designed to change opioid prescribing behavior.
A Centers for Disease Control and Prevention report indicates that following basic childhood care and prevention guidelines could catch health concerns before they become health problems that require costly medical services later in life.
The $225-million deal will give Mylan one of two generics for the deep vein thrombosis drug.
The Milbank Quarterly has published a study that may put Sunshine skeptics on edge.
The impact health monitors have on consumer habits and on patient-physician relationships has yet to be quantified.
A US investigation into GlaxoSmithKline has stirred up internal paperwork that the UK drugmaker was looking into compliance violations in its consumer division in 2012.
Auxilium slashes headcount by 30%; poll finds majority of voters support action against tax inversions; FDA panel votes 6-4 against Actavis-backed blood-pressure pill.
The FTC is suing AbbVie and two other firms in a pay-for-delay case that could have wider implications for pharma
The London healthcare brand and research agency will be part of Omnicom's DAS Group.
The new site, which includes professional resources on diabetes, debuted online and in app form today.
An FDA advisory panel will consider evidence supporting a weight-loss indication Thursday.
The media company has added managed-markets expertise to its roster, bringing on the former head of IMS Health's global payer/provider division.
Mayo Clinic is reported to partner with Apple's iWatch for remote patient outreach; FTC sues AbbVie and Teva over pay for delay; JAMA study concludes that drugs given to patients with advanced dementia are not worth the price.
Manufacturer, agency and consulting hires and promotions
The company said in a statement that the findings indicated the Spiriva-Striverdi combination treatment could help patients "return to a more independent life."
Thomson Reuters finds the pharmaceutical industry is getting better at abandoning failures earlier.
BMS files patent suit over Merck's Keytruda; Purdue says reformulated Oxycontin curtails abuse; Lilly sues CMS over Alzheimer's disease diagnostic agent.
Gilead in talks to license Sovaldi in several countries, CMS gets over 800 comments requesting CME exemption, pharmacist tied to meningitis scare is arrested, Keytruda wins approval, RTC rebrands to Wunderman
@Point of Care has integrated IBM's much-touted Watson cognitive technology into its real-time clinical-decision platform
Lilly's long-acting insulin showed it's more effective in type 1 diabetics than Lantus, but concerns about its overall profile persist.
The FDA approved the drug previously known as pembrolizumab, now known as Keytruda, for patients with unresectable or metastatic melanoma who have taken Bristol-Myers Squibb's Yervoy (ipilimumab).
The numbers folks at the Centers for Medicare and Medicaid Services anticipate sluggish growth in US healthcare spend, but prescriptions look ready to take off.
The latest data shows an overall widening of the US.
Bloomberg reports that India's Wockhardt has become an M&A target.
Pfizer will sell two Novartis drugs in the UK.
PD-1 inhibitor launches in Japan with a lofty price tag; more Zohydro pushback; J&J developing Ebola vaccine.
Brown has stepped down as general manager of the IPG network to lead the GuideMark Health agencies as CEO.
Google's independent biotech announced today it will enlist AbbVie in its mission to cure death.
The $310,000 price for the Gaucher disease medication is typical of the rare-disease category.
Parent company CVS Caremark is changing its name to better reflect "its broader health care commitment."
Sales reps are among the pinked-slipped in Spain.
AbbVie inks agreement for oncology asset; largest single day med device recall on record; US appeals court revives Botox improper labeling/marketing case.
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.
Sanofi and Regeneron unveil Phase-III results of their PCSK9; Merck will present data on its anti-PD-1 at the end of this month; WSJ op/ed suggests US should lead fight against Ebola; Novo Nordisk kills inflammatory business unit to shift resources to diabetes and obesity; generics firm Cipla could stand to gain from Advair patent expiry.
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.
Jazz apples has launched a Crunch to Contribute campaign to raise money for one of two diabetes associations.
Illinois may be tempted to offer tax incentives for the firm to stay put.
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.
FDA inspectors have cited the manufacturer of the rare-disease drug Soliris (eculizumab) for poor manufacturing practices.
The $300,000 grant will go towards an abuse-deterrent technology.
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.
A study of psoriatic arthritis patients found greater adherence among patients whose initial treatment was a biologic, compared to those who started with a non-biologic treatment.
A Treasury report says the IRS is having trouble identifying who owes it money.
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.
A proposal by the Obama administration Friday seeks to keep contraception accessible and coverage approval at arm's length for employees of religious non-profits.
Diet and exercise can help some type-2 diabetes patients save around $500 in medical expenses every year.
J&J subsidiary Janssen has abandoned its patent lawsuit over the anti-seizure medication topiramate, which is part of Vivus's prescription weight-loss drug Qsymia.
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.
Manufacturer and Agency hires and promotions
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.
The goal is to develop companion diagnostics to match patients with cancer treatments.
Political furor over the recent spate of tax inversions is having little influence on how the government chooses its partners.
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.
The Wall Street Journal says the deal would add "another layer of intrigue" to the Allergan-Valeant hostilities.
Inspectors of Marck Biosciences found an array of problems during a October-November 2013 inspection, including mold near a sterile area that was so bad "the room had 'partially caved in.'"
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.
AstraZeneca announced the end of the investigation Tuesday.
A host of doctors has asked FDA Commissioner Margaret Hamburg to back a naming convention that would require biologics and biosimilars to have different names.
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.
Despite a collaboration with original Sovaldi owner Pharmasset in 2004, a panel ruled Roche has no rights to HCV treatment Sovaldi.
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.