DUBLIN – Could a recombinant human protein drug rejected by Glaxosmithkline plc in 2019 benefit patients with COVID-19 infection? Apeiron Biologics AG disclosed Wednesday Feb. 26 that an investigator-initiated pilot study of APN-01 is getting underway in Guangzhou, China.
BEIJING – While repurposing drugs may be a quick solution to an epidemic like COVID-19 that has a limited research window, it’s just luck as to whether an already available drug candidate exists for newly emergent diseases. Experts say it’s more realistic to develop better drugs instead of attempting to repurpose old ones.
PERTH, Australia – Sydney-based Immutep Ltd. reported positive interim data for its phase II basket trial in non-small-cell lung cancer (NSCLC) and head and neck squamous cell carcinoma for its lead immunotherapy in combination with Merck & Co. Inc.’s anti-PD-1 therapy, Keytruda (pembrolizumab).
H. Lundbeck A/S’ antibody-based migraine therapy, Vyepti (eptinezumab-jjmr), which just received FDA approval as the first and only intravenous preventive treatment for adults, enters a market forecast to grow to $7 billion by 2027. While some analysts placed Vyepti’s earnings potential at about $800 million annually, the drug itself is positioned to become a possible blockbuster, earning $1 billion annually.
NGM Biopharmaceuticals Inc. wowed investors with positive preliminary top-line results from the 24-week double-blind, randomized, placebo-controlled fourth cohort of an adaptive phase II study testing aldafermin in nonalcoholic steatohepatitis (NASH).
Paris-based Sanofi SA, responding to increasing medicine shortages and drugmakers' heavy reliance on active pharmaceutical ingredients (APIs) sourced from Asia, said it plans to create a major new API manufacturer headquartered in France.
Less than a month after landing a positive opinion from the EMA's CHMP, Esperion Therapeutics Inc. has won FDA approval for bempedoic acid as an adjunct to diet and maximally tolerated statin therapy.
During a conference call with investors, Baudax Bio Inc. CEO Gerri Henwood let out an exuberant “woohoo!” to celebrate the FDA’s approval – after two turndowns and much haggling over data – of Anjeso (meloxicam) for moderate to severe pain. Echoing her sentiment was Piper Sandler analyst David Amsellem. “It’s nice to see the pain division finally get this one right,” he said.
HYDERABAD, India – To continue expanding their footprint and capabilities beyond simple generics to biosimilars and new chemical entities, Indian pharmaceutical companies will have to improve their quality controls, compliance capabilities and, just as importantly, adopt more effective digital strategies.
PERTH, Australia – Medicinal cannabis company Zelira Therapeutics Ltd. reported that its ZLT-101 therapy met the primary endpoint of a statistically significant improvement in insomnia in a phase Ib/IIa study in patients diagnosed with chronic insomnia.
RSS
