With the clearance granted Zealand Pharma A/S for glucagon analog Zegalogue (dasiglucagon) in severe hypoglycemia, speculation began regarding how the third such product will fit into the market. Copenhagen, Denmark-based Zealand was given the go-ahead with Zegalogue in pediatric and adult patients with diabetes age six and older. Zegalogue will launch in June, and will be available by way of an autoinjector and prefilled syringe.

Ionis shares sink as Roche quits dosing phase III HD drug following IDMC opinion

Shares of Ionis Pharmaceuticals Inc. (NASDAQ:IONS) fell nearly 19% by midday after its longtime partner, Roche Holding AG, decided to stop dosing the antisense oligonucleotide tominersen in a global phase III manifest Huntington's disease study. Roche subsidiary Genentech Inc. said the move was based on an independent data monitoring committee's preplanned assessment of the drug's risk-benefit profile. While both partners expressed disappointment in what could be an final chapter for the long-running program, Evercore ISI analyst Josh Schimmer said most investors had "already written it off."

Frequency hears bad news from a phase IIa study of its lead candidate

A phase IIa study of Frequency Therapeutics Inc.’s lead candidate in treating hearing loss showed it fared no better than placebo. Interim data revealed four weekly injections of FX-322 in patients with mild to moderately severe sensorineural hearing loss showed no discernible hearing benefit. However, new data from the company’s phase Ib study of FX-322 as a single injection demonstrated hearing improvement, and that is enough to prompt Frequency to say it will continue single-dose injections in its studies. The Woburn, Mass.-based company stock (NASDAQ:FREQ) was taking a pounding at midday as shares traded 76% lower.

Asher Bio closes $55M series A round for targeted IL-2 drugs

Asher Biotherapeutics Inc. raised $55 million in a series A financing round to take forward a series of engineered cytokines designed to selectively activate T cells or other immune effector cells, in order to eliminate both the toxicities and the loss of efficacy that can result from indiscriminate activation.

Australia’s TGA clears local manufacture of Astrazeneca’s COVID-19 vaccine

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has approved Australian manufacture of Astrazeneca plc’s COVID-19 vaccine (ChAdOx1-S), which is being manufactured by CSL Ltd. In February, the TGA granted provisional approval to the overseas-manufactured Astrazeneca vaccine. Initial supply of the vaccine was imported into Australia, and now ongoing supply will be manufactured in Australia. CSL has a contract to manufacture 50 million doses of the Astrazeneca vaccine, which the majority of Australia’s population will receive.

Bipartisan agreement: Time to do something about U.S. Rx prices

“The time is long overdue for the United States Congress to summon up the courage to take on perhaps the most powerful special interests in the United States, and that is the pharmaceutical industry,” Sen. Bernie Sanders (D-Vt.) said in concluding a subcommittee hearing March 23 on why the U.S. has the highest prescription drug prices in the world. He noted that many bills have been introduced over the years to address drug prices and yet those prices continue to increase. The solutions offered during the hearing weren’t new, but the commitment, from both Democrats and Republicans, to do something about the cost of drugs was determined. The question now is whether the two sides can agree on a way to balance innovation with competition and value assessments to bring U.S. drug prices more in line with what other countries pay.

Dragon Boat moves China’s first anti-CSF-1R antibody candidate to the clinic

Like its distinctive name, Dragon Boat Biopharmaceutical Co. Ltd. raced to victory with the Chinese IND approval for its anti-CSF-1R monoclonal antibody candidate, BC-006, said to be the first to enter the clinic in China. Established in September 2005 as a contract research organization under U.S. firm Dragonfly Sciences Inc., the company transformed into a biotech firm after it was acquired by traditional Chinese medicine producer Guilin Sanjin Pharmaceutical Co. Ltd. for $35 million in 2013.

Deals rise above 2020; M&As behind, despite Horizon/Viela $3B join-up

Biopharma deal values in 2021 are already tracking about 12% ahead of this time last year, while M&A values have declined by 57%. As of March 23, BioWorld has recorded 462 deals, including licensings, collaborations and joint ventures, valued at $36.7 billion in 2021, as well as 36 completed M&As worth $10.4 billion. By this point last year, however, there were 407 deals worth $32.8 billion. M&As in 2020 hit 30 by mid-March and had a projected value of $24 billion, more than twice as much as this year, but including Novartis AG’s $9.7 billion buyout of The Medicines Co. in January.

Also in the news

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