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.'"
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.
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.
FDA feedback will influence a new clinical trial design, but the regulator's recent reaction was a bit of a surprise.
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.
The regulator and patients will chat for two days in October.
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.
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.
The regulator has already issued more recalls in the first half of 2014 than it has over the past nine years.
The new rules are expected to do away with the haphazard nature of facility inspections.
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.
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 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.
The painkiller's marketer will look to partner with another manufacturer to better target primary care physicians, and will also reexamine its sales territories.
The pharma payment verification site has been temporarily shut down by CMS due to incorrect information, ProPublica reported today.
The cost of fixing healthcare.gov is hovering at around $1 billion, up from the $677-million figure quoted in December
The Senate Judiciary Committee's antitrust panel is looking into how three major pharmaceutical manufacturers decided to set minimum prices for their contact lenses.
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
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.
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.
It's the second for this cancer drug in two weeks.
The lawsuit has been wending its way through the courts for a while, and, although it is being deliberated in several other venues, the decision is part of a legal dispute that puts patients in the 36 states offering federal exchanges in limbo.
The Food and Drug Administration has been intent on elevating and reorganizing its office of Generic Drugs since 2012.
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 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.
The House Energy and Commerce Committee is putting two health-related bills to vote Monday. One covers new sunscreen ingredients, the other muscular dystrophy research.
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.
The FDA began its drug review at a median time of 103 days sooner than the EMA. Being first, researchers found, often resulted in quicker approval.
Servier and Teva have been fined for keeping a generic heart medication off the market.
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.
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.
The drugstore chain will no longer sell Sudafed in West Virginia.
It's the generics maker's second recall of 2014.
The head of evidence-based medicine at Milan's health authority Alberto Donzelli has pulled down criticism of Merck's cholesterol drug ezetimibe from his website, after the drugmaker sent two cease-and-desist letters.
In what amounts to a sudden about face, CMS wants to delete the Sunshine rule's exclusion for continuing medical education.
The European Commission is rolling out a verified-account tag it hopes will connect Internet users with trustworthy drug sources.
Health insurers and pharmacies signed a letter asking the FDA to require biosimilars and branded biologics to share the same name.
Boehringer Ingelheim's experimental idiopathic pulmonary fibrosis treatment nintedanib is also an orphan drug.
The Indian Pharmaceutical Alliance makes a bid for legislators' attention.
FDA says it will fast track the blood-thinner antidote, designed to thwart runaway bleeding.
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 regulator is issuing draft guidance to address gene therapies.
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.
Guidance on promoting products in 140 characters and correcting misinformation serves as a guarded green light, says one observer.
Colorado's version of the FDA's compassionate use rule does not sit well with lobbying group Pharmaceutical Research and Manufacturers of America.
The companies resubmitted SGLT2 inihibitor empagliflozen for FDA review. The EC approved the drug in May.
FDA issued two guidance documents today for industry and its representatives to communicate online about prescription drugs and devices.
Recent FDA guidelines for health-tracking apps mean Apple's HealthKit, and similar apps, won't have to jump regulatory hurdles before going live.
The all-oral genotype 1 medication got the Breakthrough Therapy designation Friday.
The bad-ad watchdog says the promotional website for the weight-loss medication Suprenza leaves out too much information.
The regulator wants more time to discuss post-marketing requirements.
Patients have to be high-risk or Baby Boomers for coverage.
The FDA granted the label for Genentech's experimental metastatic urothelial bladder cancer treatment.
Will docs line up to glimpse their payment data—and get a chance to correct mistakes—or will low awareness overshadow the latest milestone in the law's roll-out?
The government's anti-trust agency said the drug companies colluded to push doctors toward pricier Lucentis over Avastin.
The company is settling around 4,000 cases for around $162,500 apiece.
The company announced Tuesday that the UK fraud agency is giving the company a closer look.
The regulator's latest study will use eye-tracking tools.
The regulator is allocating almost $38 million to improve data-guided decision-making.
Orange and Santa Clara counties are suing painkiller makers like Purdue and Endo, a suit akin to deceptive ad cases launched against the tobacco industry.
Roche says reps from China's antitrust agency visited one of its sites.
The FDA's seven-page letter outlines some of the problems the regulator has with one specific Sun site.
The advertising watchdog gave drugmaker Alvogen 15 days to make amends.
The Securities and Exchange Commission alleges that two doctors illegally exploited their clinical trial affiliation for financial gain.
A three-year, $1 million project seeks an equation for generics and biosimilars.
Novartis says the FDA wants more serelaxin efficacy data.
The FDA granted Breakthrough Therapy status to the duo's multiple myeloma treatment.
The regulator defends its approval decision in a web post.
Zontivity (vorapaxar) was approved for patients who have already suffered a heart attack or have arterial blockages in the legs.
The FDA has granted priority review status for the expanded-indication review.
Prompted by thousands of adverse events, the agency is said to be undertaking an extensive review of generic copies of Toprol XL.
The drugmaker sent Olysio + Sovaldi to regulators for an additional indication in HCV patients with liver scarring.
FDA warned consumers against using aspirin for primary prevention, following its denial of Bayer's request to allow marketing of aspirin for that use.
Epanova—a drug meant for patients with a high triglyceride count—won approval from FDA today, a small but symbolic win for AZ as it seeks to fend off a takeover attempt by Pfizer.
The trackable device offers a 160-degree view of a patient's insides.
Merck's ex-blockbuster allergy drug, Singulair, received a thumbs-down from an FDA advisory panel asked to consider an OTC switch.
The response period may have ended in mid-April, but some of the harshest criticisms of FDA's social media draft guidance weren't posted until the end of the month.
Two drugmakers, Purdue Pharma and Teva, have abuse-deterrent hydrocodone medications either under FDA review or in late-stage testing.
The FDA announced Tuesday its approval of lung cancer drug Zykadia for patients with metastatic ALK-positive non-small cell lung cancer.
Roll Call finds some significant increases in lobbying spend between Q4 and Q1.
Panel chair Randall Flick said QRxPharma "had not provided sufficient evidence to support a claim that Moxduo is safer than morphine or oxycodone."
The FDA designation is for an experimental, inhaled form of ciprofloxacin intended to treat a rare lung condition.
The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.
Facts tucked among the 9.2 million lines of data: 2% of doctors account for around 25% of Medicare billing.
The regulator has put off the inhaled insulin's PDUFA date by three months.
The ACA has spurred double-digit increases in demand for pharmaceuticals, new data suggest.
The FDA has issued draft guidance that funds FDA inspection of some drug compounders.
At a hearing today, Public Citizen and the generics industry are sounding off on an FDA proposal that would allow generics firms to update labels, regardless of whether the brand has or hasn't.
The Bay State is saying no to the controversial prescription painkiller.
Longtime industry critic, Congressmen Henry Waxman penned a note to Gilead CEO over the "extraordinarily high cost," of its recently approved HCV treatment Sovaldi.
A rival's late-stage trial results suggest the pain med may have a short market life. The key: an FDA division head's documented willingness to overturn the approval should another pain option surface.