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BioWorld - Wednesday, April 8, 2026
Home » Topics » Drugs, Medical technology

Drugs, Medical technology
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Postponed stamp on calendar

Preparing for COVID-19, FDA shuts down inspections, postpones meetings

March 10, 2020
By Mari Serebrov
Despite the growing concerns about the potential for the community spread of COVID-19 in the U.S., the FDA-FTC public workshop on competition in the biologics marketplace went ahead as scheduled March 9, playing to a full house with some audience members sitting in an overflow room. And all the invited speakers and people registered to speak during the open public hearing session showed up.
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Coronavirus test tube, microscope, gloved hand

WHO releases COVID-19 roadmap; funding efforts in progress

March 9, 2020
By Nuala Moran
LONDON – The World Health Organization (WHO) has released its COVID-19 R&D roadmap, highlighting the gaps in knowledge about the virus and setting out priorities for research. The organization is now calling on groups around the world to use the document – drawn up by 400 experts – to coordinate their efforts.
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India’s restriction on API exports gives rise to more calls for U.S. drug, device manufacturing

March 3, 2020
By Mari Serebrov
Against the backdrop of the global spread of COVID-19, India announced restrictions Tuesday on the export of 26 active pharmaceutical ingredients (APIs) and formulations of those ingredients.
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Empty prescription drug bottles

COVID-19 a fulcrum to push MEDS Act through Congress

March 2, 2020
By Mari Serebrov
COVID-19 is bringing more pressure to bear on Congress to pass S. 2723, the Mitigating Emergency Drug Shortages (MEDS) Act, which has been sitting in the Senate Health, Education, Labor and Pensions (HELP) Committee since Sen. Susan Collins (R-Maine) introduced it in October 2019 – a few months before the novel coronavirus emerged.
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Stock chart, upward arrow
Beware the bubble?

Coronavirus outbreak pushes Chinese biotech stocks higher despite market downturn

Feb. 6, 2020
By Elise Mak
BEIJING – Share prices of Chinese biotechs that partner with Gilead Science Inc. have surged in China this week, after the U.S. firm’s remdesivir was identified as the most promising drug candidate to treat 2019-nCoV.
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Pills in dollar sign, bottle, blister packs, money

Congress must do the seemingly impossible – seek bipartisan solutions

Feb. 5, 2020
By Mari Serebrov
Touting the efforts his administration already has taken to lower U.S. prescription drug prices through increased competition, President Donald Trump placed the burden for further action squarely on Congress during his State of the Union address Tuesday, Feb. 4.
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Brexit hourglass illustration

Brexit day arrives; industry continues to face lack of clarity as transition period begins

Jan. 31, 2020
By Nuala Moran
LONDON – Brexit finally becomes a reality at midnight central European time on Jan. 31, but for the life sciences industry uncertainty continues, as the U.K. enters an 11-month transition phase during which the terms of its future relationship with the EU must be negotiated.
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Money and stethoscope

U.S. drug prices: Is it time to look beyond a binary drug regulatory scheme?

Jan. 28, 2020
By Mari Serebrov
Combination products with digital interfaces. Antibody-drug conjugates. Complex drugs. Synthetic biologics. They’re all examples of how technology is expanding the ambit of what’s considered a drug beyond the current U.S. binary regulatory system of small molecules and biologics.
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Gavel and scales

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

Jan. 23, 2020
By Mari Serebrov
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.
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