After FDA delays pneumonia antibiotic, Cempra's shares plummet

Some analysts contend the size and cost of the FDA's recommended safety study is impractical for the North Carolina-based biotech, likely sinking its lead product.

By Judy Packer-Tursman • Dec. 30, 2016

Biogen, Ionis gifted with approval for SMA drug

The FDA okayed the first SMA drug months ahead of its PDUFA date. 

By Lisa LaMotta • Dec. 26, 2016

A look back: Top stories of 2016

2016 was a rollercoaster year full of clinical jackpots and busts, reorganizations, and dramatic economic and political twists. Here are some of the biggest headlines from the last 12 months.

By Jacob Bell • Dec. 26, 2016

Prescribed Reading: An uptick in year-end M&A

Several companies are striking deals to round out the year, while others are trying to bury bad data, and the FDA cracks down on manufacturing. 

By Lisa LaMotta • Dec. 23, 2016

Teva pays up $520M to settle bribery charges

The Israeli generic drugmaker admitted to bribing foreign government officials in Russia, Ukraine and Mexico in a past effort to boost sales.

By Ned Pagliarulo • Dec. 22, 2016

FDA warns drugmakers on misleading marketing

Two companies were hit with warning letters last week for failing to disclose risks associated with their respective drugs.

By Ned Pagliarulo • Dec. 21, 2016

FDA pushes decision on Roche MS drug to March

Ocrevus would be the first to treat one type of the disease, and would help keep Roche's portfolio fresh amid patent expirations.

By Jacob Bell • Dec. 21, 2016

Clovis lands early FDA OK for rucaparib

Approval of the biotech's advanced ovarian cancer drug helps take the sting off a costly regulatory setback earlier this year. 

By Suzanne Elvidge • Dec. 20, 2016

ADA guidelines highlight new Jardiance label

Inclusion in the guidelines will provide a competitive advantage in a crowded market.

By Suzanne Elvidge • Dec. 19, 2016

Pfizer's Chantix loses its black box warning

The big biopharma announced on Friday the FDA had agreed to remove the warning from its smoking cessation drug.

By Jacob Bell • Dec. 19, 2016

Prescribed Reading: Bad behavior abounds in biopharma

Charges have come down in a generics price-fixing investigation, while Ophthotech reports deep staff cutbacks and the FDA cautions on misleading advertising.

By Lisa LaMotta • Dec. 16, 2016

Allergan subsidiary settles kickback charges for $38M

Forest Laboratories allegedly paid doctors to encourage the prescribing of certain drugs, including the dementia treatment Namenda.

By Suzanne Elvidge • Dec. 16, 2016

FDA guidance urges vigilance to fight suspect products in drug supply chain

The agency identifies specific scenarios that could significantly increase the risk of illegitimate products entering the market and recommends how to identify them "expeditiously."

By Judy Packer-Tursman • Dec. 15, 2016

Moody's signals bigger risks for PBMs amid pricing backlash

Close ties to drug pricing negotiations, as well as a lack of transparency, will likely mean increased risk for pharmacy benefit managers going forward.

By Jacob Bell • Dec. 14, 2016

Bristol-Myers hit with marketing fine for Abilify

Off-label promotion of the antidepressant landed the biopharma in hot water with the NY Attorney General. 

By Suzanne Elvidge • Dec. 12, 2016

Prescribed Reading: Cures for pharma funding

Cures provides funding for pharma research, while AstraZeneca and Lilly continue their pursuit of an Azheimer's treatment, and CAR-Ts wow at ASH. 

By Lisa LaMotta • Dec. 9, 2016

Allergan may face patent battle over Restasis

A decision by the Patent Trial and Appeal Board means Mylan can contest six patents on Restasis, one of Allergan's top drugs. 

By Suzanne Elvidge • Dec. 9, 2016

FDA slaps Spanish API maker with warning letter

The Barcelona-based manufacturer was flagged for inadequate cleaning and equipment repair practices, as well as not providing stability data.

By Jacob Bell • Dec. 8, 2016

Former pharma execs arrested in bribery scheme

Six former Insys executives, including the ex-CEO, were arrested Thursday and charged with bribing doctors to prescribe Subsys, a fentanyl-based pain drug. 

By Ned Pagliarulo , Lisa LaMotta • Dec. 8, 2016

Sun Pharma faces new worries at key Halol plant

The large Indian drugmaker revealed the FDA has issued a Form-483 following re-inspection of the drug manufacturing facility. 

By Ned Pagliarulo • Dec. 8, 2016

Pfizer hit with record fine in UK for drug price hike

A U.K. competition regulator fined Pfizer and Flynn Pharma about $113 million for sharply increasing the price of an epilepsy drug by as much as 2600%. 

By Ned Pagliarulo • Dec. 7, 2016

Sage locks in regulatory path for postpartum depression drug

After meeting with the FDA, Sage says it will only need a few small changes to turn its current clinical programs for SAGE-547 into registrational trials. 

By Ned Pagliarulo • Dec. 6, 2016

Kite begins march to market

The CAR-T company expects to complete its application for KTE-C19 by the end of Q1 2017, giving it a chance at first-to-market honors in the emerging field. 

By Ned Pagliarulo • Dec. 6, 2016

Novartis forges ahead with lead CAR-T

The Swiss pharma plans to file for approval of CTL019 in early 2017 after presenting encouraging data at ASH over the weekend. 

By Ned Pagliarulo • Dec. 5, 2016

Eli Lilly, Boehringer secure CV label for Jardiance

The FDA gave the companies an early Christmas present, approving an expanded indication for the diabetes drug which Lilly hopes will be a catalyst for sales. 

By Ned Pagliarulo • Dec. 2, 2016