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.
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.
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.
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
An FDA advisory panel will consider evidence supporting a weight-loss indication Thursday.
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.
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.
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.
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.
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.
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.
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.