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ARS Pharmaceuticals Closes Merger with Silverback Therapeutics

Benzinga

With its needle-free administration, neffy ® may help eliminate the anxiety and hesitation associated with using an epinephrine injection device. The Company's New Drug Application (NDA) submission for neffy ® is currently under review by the U.S. if Approved. SAN DIEGO, Nov. SAN DIEGO, Nov. Silverback).

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Kyowa Kirin successfully completes acquisition of Orchard Therapeutics, a global gene therapy leader for rare diseases

Benzinga

Libmeldy is approved by the European Commission (EC) and UK Medicines and Healthcare products Regulatory Agency (MHRA). Libmeldy is approved by the European Commission (EC) and UK Medicines and Healthcare products Regulatory Agency (MHRA). TOKYO and LONDON and BOSTON, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Kyowa Kirin Co.,

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GENFIT to Acquire Clinical-stage Biopharmaceutical Company Versantis, expanding its Portfolio in Liver Diseases

Benzinga

No drugs have been approved in this indication so far and incidence is growing at epidemic rates due to an aging population and a higher prevalence of diabetes, obesity, NASH, as well as alcohol and drug-induced liver injury.

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Paul Weiss Discusses Second Circuit Decision on Falsity in Securities Fraud Cases

Reynolds Holding

2] Second, the court held that statements in which a securities-fraud defendant interprets data in a way that is ultimately endorsed by the Food and Drug Administration (FDA) are per se “reasonable” as a matter of law. [3] 8] While PMI’s FDA application was pending, two articles were published.

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Myovant Sciences Announces Corporate Updates and Financial Results for Second Fiscal Quarter 2022

Benzinga

(Sumitomo Pharma), and Myovant Sciences (Myovant) announced that they have entered into a definitive agreement pursuant to which Sumitovant will acquire all outstanding shares of Myovant not already owned by Sumitovant for $27.00 per share in cash. This corresponds to a total transaction value of $1.7 billion on a fully diluted basis.

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Davis Polk Discusses Recent SEC and CFTC Enforcement Actions

Reynolds Holding

The SEC further alleged that, soon after the press releases were published, the Food and Drug Administration (FDA) contacted the Company regarding the accuracy of the language used in the press releases, but the Company did not correct the press releases until approximately two weeks later, after its securities offering.

Banking 52
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Commissioner Dissents from SEC Rule on Climate-Related Disclosures

Reynolds Holding

If left unchecked, we may see further misuse of the Commission’s rules for political and social issues and an erosion of the agency’s reputation as an independent financial regulator. To that, I emphasize the advice that I give to would-be investors: do not rely on the marketing materials and read the prospectus instead.