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FarmaKology-Popular nausea medications linked to increased stroke risk

FarmaKology

Mar 24, 2022

Today's Company

Anavo Therapeutics

Anavo Therapeutics is the first company to systematically drug phosphatases, a rich target space previously considered undruggable for decades. We have attracted world-leading scientific expertise in phosphatase-driven disease biology and drug discovery to unlock the full potential of phosphatase-targeted allosteric modulators. In oncology, Anavo is developing multiple first-in-class therapeutic programs and will build on partnerships around its platform to establish a rich pipeline across several indications.Anavo is backed by blue-chip investors M Ventures, INKEF Capital, Taiho Ventures, and Bioqube Ventures.

News

ViiV Healthcare announces label update for its long-acting HIV treatment, Cabenuva (cabotegravir, rilpivirine), to be initiated with or without an oral lead-in period

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved a label update for Cabenuva (cabotegravir, rilpivirine) making the oral lead-in with cabotegravir and rilpivirine tablets optional. Oral cabotegravir and rilpivirine can be taken for a month to assess tolerability to the medicines prior to initiating cabotegravir and rilpivirine injections, a regimen co-developed as part of a collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson, but this oral lead-in is now optional after clinical trial data demonstrated similar safety and efficacy profiles for both initiation methods (with or without the oral lead-in).

Shionogi has filed for approval to manufacture and sell cefiderocol in Japan .

Cefiderocol has completed three global trials (a Phase 2 trial [APEKS-cUTI] in patients with complicated urinary tract infections, a Phase 3 trial in patients with carbapenem-resistant gram-negative bacterial infections [CREDIBLE-CR], and a Phase 3 trial in patients with nosocomial pneumonia [APEKS-NP]) and has been approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC). Based on the results of these clinical trials, Shionogi has filed for approval to manufacture and sell cefiderocol in Japan.

Moderna Finalizes Strategic Partnership with Australian Government

Moderna, Inc. , a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced the finalization of a strategic partnership with the Australian Federal Government to establish a state-of-the-art, domestic mRNA vaccine manufacturing facility in Australia. This finalizes the agreement in principle with the Australian Federal Government announced in December 2021.

Pfizer Granted FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus Vaccine Candidate for the Prevention of RSV in Older Adults

Pfizer Inc. today announced that its respiratory syncytial virus vaccine candidate, PF-06928316 or RSVpreF, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older.