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US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News

Executive Summary

This past week in US regulatory, legislative, legal and political news affecting the biopharmaceutical industry included an assertion by the Biotechnology Innovation Organization that if the US Supreme Court permits the process for so-called inter partes reviews to remain on its current course, not only would patent claims held by innovator drug makers likely continue to be invalidated at unprecedented levels, but investment in the biopharmaceutical sector and partnering and acquisition deals among drug companies are at greater risk of falling apart; concerns raised by a panel of biopharmaceutical executives that their efforts for creating vaccines to address emerging infectious diseases may not pay off if there's no guarantee there will be a buyer for their products; an even harsher review in the FDA's revised documents of Sarepta Therapeutics Inc.'s data for its Duchenne muscular dystrophy eteplirsen than the evaluation revealed in January before a snowed-out advisory committee meeting was rescheduled; the release of a new report sponsored by Amgen Inc. that contends 2016 promises to bring greater clarity to the American landscape for the copycat biologics; the shutdown by the National Institutes of Health of two sterile production facilities, which stemmed from an ongoing investigation launched last spring; plus other Washington news.

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US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News

This past week in US regulatory, legislative, legal and political news affecting the biopharmaceutical industry included a call by President Barack Obama for ensuring there's more opportunities for women in the fields of science, technology, engineering and math, with the man in the White House declaring the US is not going to succeed if half the team members – especially when it's the smarter half – are left on the bench and not allowed to play; charges by the Generic Pharmaceutical Association and its affiliated Biosimilars Council in public comments that AbbVie Inc.'s citizen petition demanding a public hearing must be held before the FDA issues its long-awaited biosimilars guidance on interchangebility was nothing more than a "thinly disguised" ploy to block cheaper biologics that may be substituted for the brand-name products; the release of a new report by the FDA showing the agency permitted more than 700 cheaper versions of brand-name medicines onto the US market in 2015 – more than ever before; and a warning from top US health officials the Zika virus that's been spreading throughout the Americas over the past several months is "scarier" than initially thought and therefore, Congress should no longer delay Obama's $1.9bn funding request to address the situation; plus other Washington news.

US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News

This past week in US regulatory, legislative, legal and political news affecting the biopharmaceutical industry included new rules unveiled by the US Treasury Department intended to curb the practice of corporate inversion, which ended up killing a deal under which Pfizer Inc. was planning to merge with Allergan PLC in a scheme to significantly lower the taxes New York drug giant was seeking to lower its tax rate; the FDA's approval of Celltrion Inc.'s and Pfizer Inc.'s Inflectra (infliximab-dyyb), the first monoclonal antibody biosimilar licensed in the US and only the second biosimilar approved by the agency; the oral arguments at the US Court of Appeals for the Federal Circuit in Amgen Inc.'s battle against Apotex Inc. over whether Congress intended for it to be mandatory for biosimilar makers to provide 180 days notice of commercial marketing to the reference product sponsor after the FDA licenses a copycat, even when the firms have engaged in the so-called patent dance under the Biologics Price Competition and Innovation Act; the adoption by the Senate Health, Education, Labor and Pensions' a set of 19 bills aimed at improving the efficiency and pace at which the FDA and the National Institutes of Health do their work; and the Obama administration's plan to redirect more than $500m of existing Ebola funds to Zika Virus research and development and preparation activities in light of Congress' failure to act on President Barack Obama's $1.9bn emergency supplemental request; plus other Washington news.

US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News

This past week in US regulatory, legislative, legal and political news affecting the biopharmaceutical industry included the unveiling by the US Patent & Trademark Office of new rules, set to be finalized May 1, under which patent owners will have a more level playing field for inter partes reviews, although now the process just got more expensive for everyone; the declaration by one top US health official that the government is caught in a "game of cat and mouse" because industry is reluctant "to put skin in the game" for developing products against the Zika virus until the firms know there's going to be money to support those efforts; the FDA's release of long-awaited guidance for labeling for biosimilars, which regulators said should rely largely on the relevant safety and effectiveness data used by the corresponding US-licensed innovator medicines, with appropriate product-specific modifications; and the disclosure by the Securities and Exchange Commission it had settled charges against Steven Burrill, who was accused of stealing money from a $283m venture capital fund to support his "lavish lifestyle;" plus other Washington news.

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