PERTH, Australia – In the second multi-billion-dollar pharma merger this week, CSL Ltd. has announced plans to buy Vifor Pharma Ltd. for an equity value of $11.7 billion. It’s also the second largest biopharma merger of 2021, a whisker above Merck & Co Inc.’s $11.5 billion acquisition of Acceleron Pharma Inc. in November, although way off Astrazeneca plc’s $39 billion buy of Alexion Pharmaceuticals Inc. in July. Read More
DUBLIN – Immatics NV is banking $150 million up front and could earn up to $770 million more in development, regulatory and commercial milestones from a licensing deal with Bristol Myers Squibb Co. involving IMA-401, its lead bispecific engineered T-cell receptor (TCR). Read More
The error in phase III data reported in late October that sank Galera Therapeutics Inc.’s stock (NASDAQ:GRTX) has been corrected, prompting share values to nearly double on Dec. 14. The error, according to J. Mel Sorensen, Galera’s president and CEO, had resulted in a false “p” value, leading the company to report the study had failed to achieve statistical significance on its primary endpoint. He called the programming error that caused the confusion “quite subtle.” Read More
Every year, the BioWorld team takes time to look back and assess the market-moving and life-changing stories and trends of the year. Without a doubt, COVID-19 shook humanity to the core, again. And like glioblastoma, the tentacles of COVID-19 invaded far beyond the obvious and ultimately changed the world. So that’s our top story of the year. But the biopharmaceutical industry is resilient and responsive. Even though there were tectonic shifts in efforts to bring an armamentarium of COVID-19 vaccines and therapeutics to patients with record-breaking speed, work continued on other fronts, because people are still getting sick with cancer, succumbing to horrible diseases like Alzheimer’s and issues such as the battle over drug prices rage on. Read More
PERTH, Australia – Australia attracted international attention in July when a Federal Court ruled that artificial intelligence can be named as the inventor of a patent. In Thaler v. Commissioner of Patents, Federal Court Justice Jonathan Beach ruled that under Australian patent law, inventors don’t necessarily have to be human. The decision challenges the assumption that only human beings can be inventors. Beach did rule, however, that an AI system cannot apply for a patent or receive a patent. Read More
While biopharma companies across the world pulled out all the stops in 2021 to develop and manufacture COVID-19 vaccines and therapies, the pandemic highlighted supply chain weaknesses, spurring demands in many countries for more domestic manufacturing and less reliance on production in other countries. Read More
In China, 2021 saw a number of regulatory efforts aimed at encouraging companies developing novel drugs. As a result, analysts expect that impact investment and investors would allocate capital to “truly innovative oncology drugs” so 2022 could see a more supportive ecosystem for the development of rare disease treatments in China. Meanwhile, they believe that me-too and me-worse drugs, which have accounted for a large portion of China’s drug market, would have a more difficult time getting marketing approval. Read More
Two trials presented at the annual meeting of the American Society of Hematology (ASH) showed that treatment with the antithrombin inhibitor fitusiran reduced the bleeding rate in patients with severe hemophilia by roughly 90%, regardless of whether they had type A or B, and whether they had developed antibodies to recombinant clotting factors. Read More
Little more than a year since FDA approval of its COVID-19 vaccine, Pfizer Inc. has published final phase II/III data on its oral antiviral candidate, Paxlovid (nirmatrelvir + ritonavir), confirming that, for non-hospitalized, high-risk adults with COVID-19, taking the drug within three days of symptom onset reduced all-cause risk of hospitalization or death by 89% vs. placebo. Read More
Cardiologist Robert Califf has been nominated a second time to lead the FDA, and drug pricing was again high on the agenda at the Dec. 14 Senate hearing for his nomination. Read More
Rnaimmune Inc., which in April raised a $10 million seed round to support its discovery and development of RNAi therapies, said it is now studying the neutralizing effects of its mRNA-based COVID-19 vaccine candidate on the Omicron variant. Read More
New hires and promotions in the biopharma industry, including: Acadia, Affinia, Awakn, Cartesian, Cerecin, Durect, Dynavax, Gamma, Hemoshear, Immunogenesis, Mind Cure, Mind Medicine, Mirus, Psyched Wellness, Sernova, Spark. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Hematology annual meeting, including: Actinium, Adagene, Affimed, Agios, Allogene, Annexon, Aprea, Arcellx, Astrazeneca, Autolus, Beigene, Editas, Emmaus, Epizyme, Equillium, Fate, Freeline, Gamida, GBT, Genentech, Glycomimetics, GSK, Hutchmed, I-Mab, Imara, Kite, Kura, Sutro. Read More
Biopharmas raising money in public or private financings, including: Ampio, Anheart, Bellus, Cargene, Deliver, Erytech, Evolus, Global Blood, Neurosense, Phosplatin, Propanc, Relmada and Zealand. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biohaven, Cellular Biomedicine, Egetis, Enlivex, Genmab, Janssen, Novavax, Nurix, Nuvation, Pfizer, Therapeuticsmd, Veru. Read More
