Industry News Government & Regulatory

December 21, 2020

Executive Summary
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered (or self-administered) to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs.
Industry News
Early data show two doses of Oxford/AstraZeneca vaccine provoked good immune response
Reuters, December 17, 2020
 
Biogen to pay $22 million to resolve U.S. drug charity kickback probe
Reuters, December 17, 2020
 
States report confusion as feds slash vaccine shipments, and Pfizer says it has ‘millions’ of unclaimed doses
The Washington Post, December 17, 2020
 
GSK puts up to $815M on the table for Surface Oncology's antibody
FierceBiotech, December 17, 2020
 
Government & Regulatory
FDA Advisers Back Authorization of Moderna’s Covid Vaccine
Bloomberg, December 17, 2020
 
Pence and Biden will get COVID-19 vaccine shots to build public support
The Hill, December 17, 2020
 
FDA grants priority review to Keytruda-chemotherapy regimen for esophageal cancer
Healio, December 17, 2020
 
AbbVie's Botox wins reprieve as agency bars Evolus' Jeaveau for alleged trade-secrets theft
FiercePharma, December 17, 2020
 
Industry News
Reuters, December 17, 2020

Oxford University’s COVID-19 vaccine candidate has a better immune response when a two full-dose regime is used rather than a full-dose followed by a half-dose booster, the university said on Thursday, citing data from early trials.

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Reuters, December 17, 2020

Biogen Inc has agreed to pay $22 million to resolve U.S. allegations that it illegally used two charities that help cover Medicare patients’ out-of-pocket drug costs as a means to pay them kickbacks to use its multiple sclerosis drugs.

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The Washington Post, December 17, 2020

Officials in multiple states said they were alerted late Wednesday that their second shipments of Pfizer-BioNTech’s vaccine had been drastically cut for next week, sparking widespread confusion and conflicting statements from Pfizer and federal officials about who was at fault.

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FierceBiotech, December 17, 2020

GlaxoSmithKline is stumping up $85 million upfront and up to an extra $730 million in biobucks for Surface Oncology’s early-stage antibody asset.

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Government & Regulatory
Bloomberg, December 17, 2020

Moderna Inc.’s Covid-19 vaccine won backing from a panel of experts who advise U.S. regulators, setting the stage for its shot to be the second vaccine cleared in the U.S.

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The Hill, December 17, 2020

Vice President Pence and President-elect Joe Biden will receive the vaccine for the novel coronavirus publicly as part of an effort by officials to build public confidence in the critical shot.

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Healio, December 17, 2020

Pembrolizumab plus fluoropyrimidine-based chemotherapy received FDA priority review for the first-line treatment of locally advanced unresectable or metastatic esophageal and gastroesophageal junction cancer, according to a press release.

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FiercePharma, December 17, 2020

AbbVie's aiming to make the most out of its new moneymaker Botox, gained in its Allergan megamerger last year, and it just scored a legal win—against a much smaller rival—that should help.

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