FDA To Scrap Controversial ‘Unapproved Drugs Initiative’
Additional reports are on a new HIV medication for babies and on AstraZeneca, Biogen, Kinaset and DeepMind, as well.
Stat:
FDA Spikes A Drug Approval Program That Inadvertently Led To Price Hikes
After years of mounting criticism, the federal government is planning to end a controversial program that forces drug makers to win regulatory approval for medicines already on the market that were never actually approved. The Unapproved Drugs Initiative was launched in 2006 to gather data on numerous medicines that had been available for years on a grandfathered basis because they predated stricter approval requirements. More recently, the initiative generated complaints that some companies established monopolies after winning regulatory approval for a medicine, which in turn, led to big price hikes or shortages in some cases. (Silverman, 11/30)
In HIV drug news —
The New York Times:
Berry-Flavored H.I.V. Medication Is Ready For Babies
The first infant formulation of dolutegravir, an important first-line H.I.V. medication, will be available soon under an agreement between several pharmaceutical companies and global health initiatives. The new formulation will be strawberry flavored and come in a tablet that dissolves in water or juice so babies can swallow it. (McNeil Jr., 11/30)
Stat:
Medicines Patent Pool Expands Deal For Access To Key HIV Drug
In a bid to expand access to a key AIDS drug, ViiV Healthcare and the Medicines Patent Pool reached an agreement that will allow generic manufacturers to provide the Tivicay treatment to four upper-middle-income countries by 50% to 70% off existing pricing. The arrangement will make it possible for lower-cost versions to reach Azerbaijan, Belarus, Kazakhstan, and Malaysia after the countries balked at being excluded from a 2014 licensing agreement that covers dozens of lower and middle-income nations. (Silverman, 11/30)
In other pharmaceutical and biotech news —
Reuters:
AstraZeneca Sells Former Blockbuster Cholesterol Drug For $320 Million
AstraZeneca said on Tuesday it would sell rights to its erstwhile blockbuster cholesterol drug, Crestor, to German pharmaceutical company Gruenenthal GmbH for an upfront payment of $320 million as the British drugmaker focuses on its cancer treatments portfolio. (B, 12/1)
Stat:
In Big Bet, Biogen Pays $1.5B For Rights To Once-Failed Depression Treatment
Biogen, placing a major bet on a once-failed treatment, is paying $1.53 billion for the commercial rights to a Sage Therapeutics’ oral depression drug that disappointed in its last major clinical trial. Under the agreement, announced Friday, Biogen will give Sage $875 million in cash and buy $650 million worth of its stock at a 40% premium. In exchange, Biogen is entitled to 50% of the U.S. profits from zuranolone, a depression drug that could win approval in 2022 if proven safe and effective, and an earlier-stage treatment for movement disorders. (Garde and Feuerstein, 11/27)
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Bullish On Its Asthma Treatment, Kinaset Forges Ahead In Unusual Times
Launching a clinical trial for a drug intended to treat severe asthma during a respiratory pandemic — particularly one that seems to hit people with some types of asthma particularly hard — could be a risky move. But that’s precisely what Kinaset Therapeutics is planning to do early next year. (Sheridan, 11/30)
Stat:
DeepMind's Protein-Folding AI Tackles One Of Biology's Biggest Challenges
At the start of a biennial contest to predict the structure of proteins, the expectations for Google’s artificial intelligence unit DeepMind couldn’t have been higher. Think Mike Tyson in the mid-1980s: Everyone was expecting a knockout. (Ross, 11/30)
