Swedish Orphan Biovitrum AB shares (STO:SOBI) fell 25% Friday as investors behind Agnafit Bidco AB, previously poised to pay about SEK72.17 billion (US$7.97 billion) for the company, withdrew their bid as shares tendered fell just short of the 90% needed to complete the deal. The bid was seen as likely to succeed after Investor AB, which owns 35% of the capital and votes in Sobi, supported it.

Omicron presents a greater risk of reinfection compared to Delta, Beta

LONDON – The latest epidemiological data from South Africa show it has entered a fourth wave of the COVID-19 pandemic, fueled by the Omicron variant of concern that was first detected in the country in late November. “We have moved from a total of 2,465 new cases last Thursday, when this variant was announced, to yesterday’s high of 11,535 [PCR confirmed infections],” said health minister Joseph Phaahla, in a briefing on Dec. 3. At the same time, scientists in South Africa published a preprint detailing real world evidence of an increased risk of SARS-CoV-2 reinfection associated with the emergence of Omicron.

Ardelyx going solo with IBS-C therapy Ibsrela, marketing to start next year 

Having made known its hopes for a partner since well before the approval of Ibsrela (tenapanor) in September 2019, Ardelyx Inc. is launching the first-in-class, sodium/hydrogen exchanger 3 inhibitor independently in the second quarter of 2022. Cleared by the FDA for irritable bowel syndrome with constipation, Ibsrela could pay off for Ardelyx by way of its different mechanism of action and market validation by peers. Already available for IBS-C are guanylate cyclase-C agonists Linzess (linaclotide, Abbvie Inc./Ironwood Pharmaceuticals Inc.) and Trulance (plecanatide, Bausch Health Cos. Inc.). Shares of Ardelyx (NASDAQ:ARDX) were trading midday at $1.88, up 18 cents, or $10%.

Longeveron’s stock jumps on orphan designation

Longeveron Inc.’s share price (NASDAQ:LGVN) had jumped about 30% after the FDA awarded orphan designation to Lomecel-B, allogeneic bone marrow-derived mesenchymal stem cells, for treating hypoplastic left heart syndrome. The designation came two weeks after the FDA granted rare pediatric disease designation for Lomecel-B to treat the life-threatening congenital heart defect in infants. The Miami-based company just initiated a phase II study in Japan for the indication with a target enrollment of 45 subjects and three cohorts to evaluate Lomecel-B’s safety and efficacy in older, frail Japanese subjects. Top-line results of a phase IIb study of Lomecel-B in aging frailty that were reported in late September showed statistically significant reduction in serum levels of soluble TIE-2 in dose-dependent fashion at day 270 compared to placebo.

European HTA – where two worlds collide

The rise of large national health care systems, mainly in Europe, has created an ongoing tension with the free market ethos of the pharma industry. After years of painstaking and costly research, drug makers want that moment when they can reap the rewards for their hard work bringing an innovative new therapy to the market. But in countries in Europe and beyond where there are national health care systems with stringent cost constraints, it’s not feasible to meet these price demands, at least without some form of rationing to keep down expenditure.

Former pharma CFO charged with insider trading

Usama Malik, Immunomedics Inc.’s former chief financial officer, and his former partner, Lauren Wood, face SEC charges related to insider trading in Immunomedics’ stock. While at Immunomedics, which has since been acquired by Gilead Sciences Inc., Malik learned that the FDA had permitted the company to halt a clinical trial for sacituzumab govitecan, later approved as Trodelvy, due to “compelling” efficacy against triple negative breast cancer. Although he was subject to a trading blackout, Malik immediately tipped Wood and three family members, the SEC alleged in a civil complaint filed Dec. 2.

SEC finalizes rules on foreign companies

The U.S. SEC adopted final amendments Dec. 2 to its rules implementing 2020’s Holding Foreign Companies Accountable Act (HFCAA). The amendments finalize interim final rules that were adopted in March but add a few modifications. Besides clarifying how the new requirements apply to various entities, the amendments establish the procedures the commission will follow in identifying issuers and prohibiting trading by certain issuers under the act.

Newly identified variant has large effects on two aspects of cardiovascular risk

The Amish are a religious community whose members live in parts of the Mid-Atlantic U.S. – and in some ways, in the pre-industrial age. For religious reasons, the community eschews the ownership of motor vehicles and the use of many electrically powered objects. As a population, the Amish have low levels of cardiovascular disease. That epidemiological fact has led to the joke that the Amish diet consists of meat, potatoes, and 20 miles of walking a week. Though the exercise-intense lifestyle that comes with rejecting many modern conveniences is no doubt a contributor for their low rates of heart disease, apparently, advantageous genetics play a role, too.

Also in the news

Aclaris, Amicus, Aqilion, Ascletis, Astrazeneca, Bayer, Beigene, Biotheus, BMS, Bone, Celyad Oncology, Chemomab, Chiesi Global Rare Diseases, Clarus, Eli Lilly, Enochian, Esperion, Eupraxia, Eusa, Everest Medicines, Geovax, Henlius, Hepagene, Hutchmed, I-Mab, Immunicum, Immunomedics, Innocare, Innovent, Johnson & Johnson, Junshi, Longeveron, Neurona, Noramco, Petros, Protagonist, Providence, Psyence, Revive, Scynexis, SK Life Science, Ultimovacs, Valneva