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.
The Japanese drugmaker is looking to add as much as a year onto the patent life of some of its drugs after the DEA dragged out their scheduling decisions.
Tech site Venturebeat, citing anonymous sources, says doctors are too overwhelmed and weary to evaluate how many steps you took this weekend.
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.
GlaxoSmithKline, Actelion, Sanofi and Roche are said to be among a host of suitors.
These healthcare plans allow employees and employers to avoid ACA penalties but provide little coverage.
The regulator and patients will chat for two days in October.
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.
A study indicates consumers stop using them at the six-month mark.
CureDuchenne is giving biotech Prosena $7 million to help its Duchenne Muscular Dystrophy treatment move along.
Cologuard was the first approved fecal-based screening test for the disease, and it was also the first product the FDA and CMS approved on the very same day through the so-called Parallel Review program.
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.
Layoffs are reported to be in the offing.
Half-measures, like diabetes educational materials without a part B, fared poorly.
The regulator has already issued more recalls in the first half of 2014 than it has over the past nine years.
The generic ED pills sell for five cents less than Pfizer's branded blue pill, but the undercutting is a bit deeper.
The new rules are expected to do away with the haphazard nature of facility inspections.
The World Health Organization rules on untested Ebola drugs, while Mapp Biopharma has already run out of its experimental antibody.
Hires and promotions for manufacturers and agencies
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 Scottish Medicines Consortium gave a thumb's down to GSK's drug and a Boehringer COPD drug.
A greenlight could garner Pfizer $1B in sales.
A group of investors has drawn up a list of business principles which includes not disparaging biosimilars as being inferior to branded biologics.
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 experimental drug is being reviewed for patients with intermediate or high-risk myelofibrosis.
Three House democrats are asking the FDA to get the chemical out of US drugs ASAP.
Medibid users auction up care in exchange for a low price.
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.
The FDA issued a Warning Letter over unapproved drug claims published in Spanish.
Health insurer WellPoint found patients chose lower-priced MRIs when shown how much locations charged for the very same procedure, but the motivation is murky.
The Illinois company says it is keeping the US as its home base, which means no inversion benefit.
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.
Soonish would be good, since a Novartis subsidiary filed a biosimilar with the FDA last month.
The drugmaker is asking the FDA to approve the drug for polycythemia vera patients.
The decades-old drug is winning prescriptions through marketing, but has a free-pass when it comes to clinical trial data.
The latest additions and promotions from the industry.
The pharma payment verification site has been temporarily shut down by CMS due to incorrect information, ProPublica reported today.
The PBM dropped 25 more drugs from its formulary.
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.
Novartis is apologizing to Japan after the Ministry of Health, Labor and Welfare said the company had dragged its feet reporting adverse events for two of its cancer drugs.
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 cost of fixing healthcare.gov is hovering at around $1 billion, up from the $677-million figure quoted in December
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.
Stand Up To Cancer is kicking off a PSA that features Grammy-winner Jennifer Hudson and a Genentech scientist.
The Senate Judiciary Committee's antitrust panel is looking into how three major pharmaceutical manufacturers decided to set minimum prices for their contact lenses.
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.
The American Academy of Pediatricians says an AstraZeneca drug for preemies should be used less often, and the drugmaker is fighting back with an ad campaign that says the new guidelines put too many at risk.
Generics made up almost 75% of prescriptions in the United Kingdom last year.
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?
Last week, the former FDA branch chief who originally approved LASIK machines asked FDA to reconsider its denial last month of his petition to ban these devices.
The FDA slapped a Breakthrough Therapy label on the CLL indication pursuit in February.
The FDA's Center for Drug Evaluation and Research's Office of Communications wants a system that will help assess its messaging reach across the interwebs and its many forums.
The company plans to spin off its pharmaceutical unit.
AstraZeneca's hope is that the blood test could replace tissue samples and be used to identify patients who could benefit from its lung drugs.
A National Institutes of Health-funded study of over 18,000 patients has identified six new genetic risk factors associated with Parkinson's Disease.
The drug did not hit its Phase III primary target of improving progression-free survival.
The PMR Charities Golf Classic teed up more than $20,000 for St. Jude Children's Research Hospital.
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.
Novartis subsidiary Sandoz announced Thursday that the FDA has agreed to review its filgrastim biosimilar which is already approved in 40 countries.
Targiniq ER combines the prescription opioid oxycodone and naloxone, which is often used to treat overdoses.
The Wall Street Journal reports that 44% of dermatologists and plastic surgeons polled in a Sanford Bernstein survey said they would consider Botox alternatives if Allergan becomes a Valeant subsidiary.
AstraZeneca, GlaxoSmithKline, Takeda, Pfizer and Eli Lilly are among seven drugmakers making their discarded molecules available in what amounts to a molecule library.
Biogen Idec is seeing strong sales for blockbuster MS drug Tecfidera, especially overseas where it's beginning to catch fire this summer.
ProPublica reports that doctors are struggling with a time-intensive registration process and are getting an error message that CMS says is not an error message.
The FDA greenlighted the drug for three cancers.
A $225-million deal with US biotech ArmaGen gives Shire worldwide commercialization rights to an experimental enzyme replacement therapy.