FTC Won’t Challenge Amazon’s $3.49 Billion One Medical Deal

 The Federal Trade Commission won’t challenge Amazon.com Inc.’s $3.49 billion acquisition of One Medical parent 1Life Healthcare Inc., according to people familiar with the decision, a move that will allow the deal to close later this week.

The agency plans to issue a letter to the companies warning them that the investigation remains open despite the expiration of the statutory deadline for the antitrust review, the people said, speaking anonymously to discuss a pending deal. The FTC also issued a so-called pre-consummation warning letter when the online retail giant purchased film studio Metro-Goldwyn-Mayer last year.

The One Medical merger marks the second time that the FTC under progressive Chair Lina Khan has declined to block a major deal by Amazon, though the agency’s long-running probe into the retailer continues.

“The FTC’s investigation of Amazon’s acquisition of One Medical continues,” FTC spokesperson Douglas Farrar said. “The commission will continue to look at possible harms to competition created by this merger as well as possible harms to consumers that may result from Amazon’s control and use of sensitive consumer health information held by One Medical.”

The agency intends to continue probing whether Amazon uses its market power to gain advantages over rivals in the concierge medicine industry, and ensure that the online retailer gains full consent from consumers for any new uses of health information, said an FTC official, who requested anonymity to discuss the agency’s ongoing concerns.

Amazon declined to comment. One Medical didn’t respond to a request for comment.

https://finance.yahoo.com/news/ftc-won-t-challenge-amazon-211559119.html

Akebia Gets Interim Response to Appeal for Vadadustat for Kidney Disease Linked Anemia

 Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the company received a second interim response from the U.S. Food and Drug Administration to its Formal Dispute Resolution Request regarding the Complete Response Letter for vadadustat received in March 2022.

Akebia received notification from the Office of New Drugs (OND), Center for Drug Evaluation and Research, that due to agency resource constraints and staffing needs the deciding authority for the appeal will now be Peter Stein, M.D., Director, OND. The appeal was originally assigned to a Senior Advisor within the OND.

Dr. Stein has indicated a need to seek internal consultation with nephrology, cardiology and liver safety experts in the Office of New Drugs to complete the review and render a decision. Dr. Stein indicated that he will do all he can to facilitate the appropriate meetings and discussions given the delay resulting from the staffing change. Akebia expects to be notified of a response to the appeal within thirty days of Dr. Stein completing the discussions and any required follow up.

https://finance.yahoo.com/news/akebia-therapeutics-received-interim-response-113000748.html

Merck's COVID-19 Treatment Fails To Prevent Infection In Household Exposure

 

• Merck & Co Inc (NYSE: MRK) Lagevrio (molnupiravir) did not demonstrate a statistically significant reduction in the risk of COVID-19 following household exposure to another individual with COVID-19.

• The Phase 3 MOVe-AHEAD trial evaluated people who did not have COVID-19 at baseline (confirmed by a negative baseline SARS-CoV-2 test and no signs and symptoms) but lived with someone who was recently diagnosed with COVID-19.

• The Lagevrio-treated group was observed to be 23.6% less likely than those who received a placebo to develop COVID-19 through Day 14.

• Lagevrio is approved or authorized in several markets, including the U.S., U.K., Australia, China, and Japan, for certain adults diagnosed with COVID-19. The treatment is not authorized for pre-exposure or post-exposure prophylaxis to prevent COVID-19.

• Last year, the FDA revised the Emergency Use Authorization for Merck COVID-19 pill molnupiravir, explaining that it should be used only if other treatments are unavailable or clinically appropriate.

https://finance.yahoo.com/news/mercks-covid-19-treatment-fails-194606447.html

Pfizer Maternal Vaccine Candidate OKd for Priority Review

 

• U.S. FDA has set an action date for August 2023. If approved, RSVpreF would be the first vaccine for administration to pregnant individuals to help protect against the complications of RSV disease in infants from birth through six months

• This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency (EMA) under accelerated assessment for both older adults and maternal immunization

• The maternal immunization regulatory filings are supported by results of the pivotal Phase 3 trial MATISSE, which will be presented to the CDC’s Advisory Committee on Immunization Practices (ACIP), as well as during the ReSViNET Foundation’s 2023 Global Conference, on February 23

https://finance.yahoo.com/news/u-fda-accepts-biologics-license-114500315.html

Biohaven SMA therapy fast tracked

 Biohaven Ltd. (NYSE: BHVN; "Biohaven") announced today that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for taldefgrobep alfa, a novel anti-myostatin adnectin, for the treatment of spinal muscular atrophy (SMA). Fast Track designation enables important new drugs to reach patients earlier by facilitating more frequent communications with the FDA and expeditious review of a drug which treats a serious condition and fills an unmet medical need. Biohaven previously received orphan drug designation from the FDA for taldefgrobep in the treatment of SMA.

SMA is a rare, progressively debilitating motor neuron disease in which development and growth of muscle mass are compromised, resulting in progressive weakness and muscle atrophy, reduced motor function, impaired quality of life and often death. Inhibition of myostatin, a naturally occurring protein that limits skeletal muscle growth, an important process in healthy muscular development, is a potential therapeutic target for SMA.

Taldefgrobep has the potential to be a novel therapy to be used in combination with disease modifying therapies to enhance muscle function by blocking myostatin activity. Taldefgrobep's novelty in a field of myostatin inhibitors is based on its mechanism of action. It binds to myostatin to both lower overall myostatin levels and also function as a receptor antagonist, thereby blocking myostatin signaling in skeletal muscles.

https://finance.yahoo.com/news/biohavens-taldefgrobep-alfa-receives-fda-123000959.html

Icosavax fast tracked for RSV vaccine

 Icosavax, Inc. (Nasdaq: ICVX), a biopharmaceutical company leveraging its innovative virus-like particle (VLP) platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases and a vision of creating pan-respiratory vaccines for older adults, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IVX-A12, a bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) VLP vaccine candidate, in older adults 60 years of age and above.

According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fulfill an unmet medical need. An investigational drug that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

https://finance.yahoo.com/news/icosavax-granted-fda-fast-track-130000491.html

Alnylam Gets OK for Application for ONPATTRO® (patisiran) for Cardiomyopathy of ATTR Amyloidosis

 -Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (sNDA) for patisiran, an investigational RNAi therapeutic in development for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis. The FDA has set an action date of October 8, 2023 under the Prescription Drug User Fee Act (PDUFA). In their file acceptance letter, the FDA stated that they have not identified any review issues. The Agency also noted that they are planning to hold an advisory committee meeting to discuss the application. Patisiran is the established name for ONPATTRO®, which is currently approved by the U.S. FDA for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.

"ATTR amyloidosis with cardiomyopathy is an increasingly recognized cause of heart failure for which there are limited treatment options. The FDA’s acceptance of our sNDA for patisiran is a positive step forward as we work to bring patients with ATTR amyloidosis with cardiomyopathy a new treatment option that addresses the underlying cause of disease and has the potential to meaningfully improve functional capacity and quality of life," said Rena N. Denoncourt, Vice President, TTR Franchise Lead. "The acceptance also marks another important milestone as we continue to build an industry-leading franchise for the treatment of ATTR amyloidosis."

https://finance.yahoo.com/news/alnylam-announces-u-food-drug-130000470.html