Drugs

Shortage of MMR vaccine in Mexico deepens on quality issues

January 24, 2020

BOGOTA, Colombia – A two-year-old shortage of measles, mumps and rubella (MMR) vaccine in Mexico has become more serious, with 2020 starting out with renewed complaints of even lower availability of the vaccine all over the country.

Securities class action suits a growing fact of life for life sciences

January 23, 2020

By Mari Serebrov

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Whether large or small, or based in the U.S. or abroad, life sciences companies are an increasingly attractive target for shareholder suits. The number of securities fraud class action suits filed in the U.S. in 2019 across all industries totaled 404, just one more than the 403 cases filed in 2018 and down from the peak of 412 in 2017, according to a new Dechert LLP report.

Australia’s TGA proposes fee increases to implement recent drug, device reforms

January 23, 2020

By Tamra Sami

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PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year. The proposal outlines three options.

Industry: Trade agreement important first step toward fairer Chinese market

January 16, 2020

By Mari Serebrov

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Time will tell whether what the Trump administration is calling a “historic” and “landmark” trade agreement with China will better enable drug and device companies to more fairly compete in the Chinese market without having to sacrifice their intellectual property (IP) and technology.

2020 U.S. Election: Where the candidates stand on drug prices

January 15, 2020

By Mari Serebrov

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In the final debate before the Iowa caucuses, the six leading contenders to be the Democratic presidential candidate had an opportunity to lay out how they would deal with U.S. prescription drug prices.

Rx opioid pipeline continues to flow despite enormous risks

January 14, 2020

By Mari Serebrov

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As a word to the wise in a week filled with FDA advisory committee meetings on potential new opioid drugs, the state of Oklahoma filed a lawsuit Monday against three distributors, reminding everyone in the U.S. opioid prescription supply chain of the risk of litigation and hefty penalties.

J.P. Morgan Healthcare Conference

BMS sets the stage for serial launches, with Celgene assets at core

January 13, 2020

By Michael Fitzhugh

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SAN FRANCISCO – Atop the stage where, just a year ago, he'd detailed the then-new $74 billion acquisition of Celgene Corp, Bristol-Myers Squibb Co. CEO Giovanni Caforio told attendees of this year's J.P. Morgan Healthcare Conference he intends to plunge ahead with "the agility and speed of a biotech company."

Rx price hikes not just a symptom of ‘greedy’ drug companies

January 10, 2020

By Mari Serebrov

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As regular as clockwork, U.S. patients were hit with a spate of price hikes on prescription drugs last week – even as they were faced with once again having to meet their hefty annual deductibles.

Year in Review: From capital markets to CRISPR, 2019 a pretty good year for biopharma

December 30, 2019

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For biopharma, 2019 can be described as a terrific year – with a few asterisks. The financial markets were flourishing, with venture capital dollars, in particular, flowing to the sector, while dealmaking reached historic proportions. Meanwhile, scientific breakthroughs led the way as cell and gene therapies gained ground, the first signs of success emerged with new technologies like CRISPR and the long-awaited promise of genomics found its way to the front lines of health care.

U.S. spending bill to ease upcoming transition for ‘deemed’ biologics

December 19, 2019

By Mari Serebrov

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One sentence buried more than 1,500 pages into a fiscal 2020 spending bill the U.S. Senate passed Thursday could open the door to a broader range of insulin biosimilars. The provision, requested by the FDA, expands the definition of a “biological product” to include chemically synthesized polypeptides. The provision, requested by the FDA, expands the definition of a “biological product” to include chemically synthesized polypeptides.