How some US companies are responding to Roe decision

 The U.S. Supreme Court on Friday overturned Roe v. Wade, a ruling that for nearly 50 years secured the federal right to obtain an abortion. The case also struck down a 1992 case, Planned Parenthood v. Casey, which affirmed the right to obtain an abortion up until about 24 weeks of pregnancy.

Following a rare leak from the Supreme Court last month suggesting Roe v. Wade would be overturned, companies including Tesla (TSLA), Amazon (AMZN), and Apple (AAPL) announced policies that would reimburse employee travel expenses incurred to obtain abortion care barred within their home state.

In response to Friday's ruling, a number of large corporations have newly announced or reiterated support to cover travel costs for U.S. employees seeking abortion services. We've collected many of these responses below, and will update this list as developments warrant.

Disney (DIS)

"We have communicated directly with our employees today that we recognize the impact of the ruling and that we remain committed to providing comprehensive access to quality and affordable care for all of our employees, cast members and their families, including family planning and reproductive care, no matter where they live," a Disney spokesperson told Yahoo Finance. "Disney employees who may be unable to access care in one location have affordable coverage for receiving similar levels of care in another location. This travel benefit covers family planning (including pregnancy-related decisions)."

Mastercard (MA)

A spokesperson for Mastercard confirmed earlier reports to Yahoo Finance that it will fund travel and lodging for employees seeking abortions outside their home states beginning in June.

"We will continue to offer employees access to the same healthcare that is available today wherever they live," the spokesperson said. "And, any travel support is consistent with other services that have been similarly supported."

JPMorgan (JPM)

"Our health care plans have historically covered travel benefits for certain covered services that would require travel,” JPMorgan told employees in a memo obtained by CNBC. “Beginning in July, we will expand this benefit to include all covered services that can only be obtained far from your home, which would include legal abortion.”

Netflix (NFLX)

The streaming giant will offer travel reimbursement coverage for its full-time U.S. employees and their dependents who need to travel for cancer treatment, transplants, gender affirming care, or abortion through their company health plans.

Microsoft (MSFT)

“Microsoft will continue to do everything we can under the law to support our employees and their enrolled dependents in accessing critical healthcare – which already includes services like abortion and gender-affirming care — regardless of where they live across the U.S," a Microsoft spokesperson told Yahoo Finance.

DICK'S Sporting Goods, Inc. (DKS)

DICK'S CEO Lauren Hobart said in a LinkedIn post that in response to Friday's ruling the company will provide up to $4,000 in travel expense reimbursement for employees living in states that restrict access to abortion to travel to the nearest location where care is legally available. This benefit will also be extended to employee spouses or dependents enrolled in the retailer's medical plan, along with one support person.

Tesla (TSLA)

In its 2021 Impact report published on May 6, Tesla said the electric vehicle maker will cover the travel and accommodation lodging support for employees who may need to seek healthcare services that are unavailable in their home state.

https://finance.yahoo.com/news/corporate-america-responding-roe-v-wade-being-overturned-162515288.html

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Revive Therapeutics Update on Phase 3 Trial for Bucillamine in COVID

 Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.

Following the Company receiving positive comments from the FDA in regards to the Company's request to determine and agree on the Study's potential new primary efficacy endpoints and the Company’s submission of a Data Access Plan (“DAP”) to the FDA, the FDA has accepted the DAP to allow for the unblinding of the pre-dose selection data. The Company will now proceed to unblind the pre-dose selection data to potentially support the amended Study protocol with the new primary efficacy endpoints. The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcome observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization.

The Company believes that with the Omicron variant, including the BA.2 variant, being the dominant strain over the Delta variant, there is an urgent need to treat symptom resolutions in addition to preventing hospitalizations.

https://finance.yahoo.com/news/revive-therapeutics-provides-phase-3-154100211.html

Amryt to Pursue Formal Dispute Resolution of CRL

 Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company focussed on acquiring, developing and commercializing novel treatments for rare diseases, today announces that the company plans to submit a Formal Dispute Resolution Request (FDRR) for the company’s New Drug Application (NDA) for Oleogel-S10 (Filsuvez®), for the treatment of the cutaneous manifestations of Dystrophic and Junctional Epidermolysis Bullosa (EB), a rare, genetic skin disease characterized by extremely fragile skin that blisters and tears from minor friction or trauma and for which there are no approved treatment options in the US.

Amryt recently had a Type A meeting with the US Food and Drug Administration (FDA) to discuss the issues raised in the Complete Response Letter (CRL) received in February 2022 relating to Amryt’s NDA for Oleogel-S10. Following this meeting, Amryt plans to proceed to the Formal Dispute Resolution pathway in the FDA’s Center for Drug Evaluation and Research (CDER) by which NDA applicants can seek to resolve scientific and/or medical disputes that cannot be resolved at the division level.

https://finance.yahoo.com/news/amryt-pursue-formal-dispute-resolution-110000937.html

BioMarin's haemophilia gene therapy set for European debut after regulatory nod

 The European Union's drug regulator on Friday recommended conditional approval to BioMarin Pharmaceutical's treatment for haemophilia A, making it the first gene therapy for the bleeding disorder.

If approved by the European Commission, it would pave the way for a rare debut for Roctavian, also known as valoctocogene roxaparvovec, in Europe even before a nod from the U.S. regulator. An approval is usually granted following a recommendation from the European Medicines Agency (EMA).

Shares of U.S.-listed BioMarin rose nearly 2% in premarket trading as the EMA nod ends a long-drawn journey for the therapy whose application for EU approval had to be resubmitted in June last year after it was withdrawn in November 2020.

Gene therapies are typically expensive. The company did not respond to a request for comment on the pricing of the drug.

Stifel analyst Paul Matteis called the approval a "big landmark" and said it raises the prospects of a similar move by the U.S. drugs regulator, which had rejected the therapy in August 2020 citing the need for two-year data.

The EMA said its approval now is based on data from a global late-stage study of 134 male patients with severe haemophilia A, which showed an 85% reduction in bleeding rates two years after administration. (https://reut.rs/3HPJgWO)

The company now plans to resubmit its application to the U.S. Food and Drug Administration in September end. It had delayed an earlier plan to apply in June as it had to provide additional information.

https://www.marketscreener.com/quote/stock/BIOMARIN-PHARMACEUTICAL-I-8587/news/BioMarin-s-haemophilia-gene-therapy-set-for-European-debut-after-regulatory-nod-40806094/

Emergent BioSolutions : FDA to Review AV7909 Anthrax Vaccine

 Emergent BioSolutions Inc. on Friday said the Food and Drug Administration accepted for review its application seeking approval of its anthrax vaccine candidate AV7909.

The Gaithersburg, Md., maker of vaccines and therapeutics, which has spent two decades working with the U.S. government on its anthrax program, is studying the vaccine for post-exposure prevention of disease following suspected or confirmed exposure in people ages 18 through 65 when administered in conjunction with recommended antibacterial drugs.

Emergent said the FDA set a target action date for a decision in April 2023.

https://www.marketscreener.com/quote/stock/EMERGENT-BIOSOLUTIONS-INC-36547/news/Emergent-BioSolutions-FDA-to-Review-AV7909-Anthrax-Vaccine-Candidate-40805847/