DUBLIN – "Unexpected, early and bad" was how Andrea Pfeifer, CEO of AC Immune SA, characterized the news that its partner, Genentech Inc., was terminating two phase III trials of anti-amyloid beta (a-beta) antibody crenezumab in Alzheimer's disease, following an interim analysis, which suggested that neither study would reach its primary endpoint. The Lausanne, Switzerland-based company's stock (NASDAQ:ACIU) was off by 37 percent during premarket trading Wednesday but went into free fall once the market opened. It ended the day at $3.65, a drop of 66 percent on its previous close. Read More
Let's be honest. For most Americans, drug prices are affordable, especially if the drug they need is available as a generic. What's powering the current public outrage about drug prices are six- and even seven-figure launch prices for specialty drugs, along with continuous price hikes for essential drugs such as insulin, which has been used to treat diabetes for nearly a century. Read More
If there's a small hitch in the phase II/III data rolled out by Orphazyme A/S with arimoclomol against the lysosomal storage disease Niemann-Pick type C (NPC), it's that the trial missed a co-primary endpoint chosen by the FDA, and the firm plans to take the results with the heat-shock protein (Hsp) amplifier to regulators in the U.S. and EU in the first half of next year. Read More
Dewpoint Therapeutics Inc., a U.S.-German startup working to industrialize the drugging of biomolecular condensates – membraneless compartments found inside cells – has launched with a $60 million series A led by its founding investor, Polaris Partners. Samsung's Samsara Biocapital, 6 Dimensions Capital, Ecor1 Capital, Alexandria Venture Investments and Bayer AG's Leaps investment arm also participated. If successful, the company could open new avenues to working with transcription factors and RNA in cancer, neurodegenerative disorders, immune diseases and other indications. Read More
From a medical perspective, women's sexual and reproductive health is a conundrum. Health care for women of reproductive age includes the possibility of affecting fertility; meanwhile, treating pregnant women means treating two people, whose physiologies differ and whose best interests can be at odds with each other. Read More
Eric Hargan, deputy secretary of the U.S. Department of Health and Human Services, tackled the effects of Stark and anti-kickback law on health care delivery reform in a Jan. 30 public appearance, during which he did not dismiss the notion that legislation could help deal with those issues. Nonetheless, Hargan said, "There are an awful lot of small ideas" that can be administratively applied, ideas he said could advance the cause of the care delivery reform even without the help of Congress. Read More
The SEC disclosed settled charges against four public companies, including biotech Cytodyn Inc., of Vancouver, Washington, for failing to maintain internal control over financial reporting (ICFR) – in Cytodyn's case, over a period of nine consecutive years, from 2008 through 2016. Read More
Amgen Inc., of Thousand Oaks, Calif., reported fourth-quarter total revenues of $6.2 billion, an increase of 7 percent over the fourth quarter in 2017. For the full year, revenues grew 4 percent over 2017 to $23.7 billion. Product sales increased 8 percent for the fourth quarter vs. the same period in 2017, and increased 3 percent for the full year. Read More
Qrons Inc., of Miami, Fla., said it reached a milestone with the development of its two candidate products, QS-100, for treating penetrating brain injuries, and QS-200, for treating concussions and other diffused axonal injuries. Both products integrate modified mesenchymal stem cells and smart synthetic material. Read More
Corvus Pharmaceuticals Inc., of Burlingame, Calif., appointed Linda S. Grais to its board and Mehrdad Mobasher vice president and chief medical officer. Read More
Trevena Inc., of Chesterbrook, Pa., said it entered securities purchase agreements with two health care-focused institutional investors, to sell 10 million shares of its common stock at $1 each in a registered direct offering for gross proceeds of $10 million. It intends to use the net proceeds for the development of its lead product candidate, oliceridine, a G-protein biased mu-opioid receptor agonist, for the management of moderate to severe acute pain, and for other general corporate purposes. Read More
