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Analysis and opinion covers key topic areas such as:
Pink Sheet
By Michael McCaughan 16 Jun 2022
The latest flurry of Executive Order activity on drug pricing reinforces the message that the President wants to own the headlines for being tough on the drug industry as Election Day looms. Looking for substance beyond that goal is a fool’s errand – but the headlines could still have significant consequences no matter who wins in November.
Topic US Election 2020
Pink Sheet
By Brian Yang 16 Jun 2022
Given the ongoing election challenges in the US, China has yet to officially congratulate Joe Biden as the next US president, although many world leaders are already hailing a reset in US foreign policy. Many are wondering if this and other moves indicate a quiet internal shift for China's high tech and life sciences sectors, just days after Beijing concluded a high-level plenary meeting outlining its priorities for the next five years.
Topic US Election 2020 China
Pink Sheet
By Bridget Silverman 19 Jan 2022
US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.
Pink Sheet
By Brenda Sandburg 01 Dec 2021
In 13-10 vote, panel finds reduction in COVID-19 hospitalizations and deaths outweighs risks. Four members say FDA should reconsider authorization if a more effective and safer therapy comes along. They concur molnupiravir should not be recommended for use in pregnancy but available to those who want it.
Pink Sheet
By Sue Sutter 16 Aug 2021
After repeatedly advising against tivozanib NDA submission on the basis of interim overall survival data that suggested a negative trend, agency ultimately concluded the final analysis did not suggest a detrimental effect in third-line renal cell carcinoma even though median overall survival was shorter than for the comparator agent, Bayer’s Nexavar.
Pink Sheet
By Brenda Sandburg 03 Aug 2021
Ahead of CDC advisory committee this fall, Merck highlights additional bacteria serotypes its Vaxneuvance protects against while Pfizer touts Prevnar 13’s indication for pneumonia.
Pink Sheet, Scrip
25 May 2021
Tap into expert coverage of the complex world of drug pricing with insights from analysts at Scrip and Pink Sheet. This eBook includes vital information about issues affecting drug pricing for the US, EU, and other global markets, including patient access, regulatory issues, commercial challenges, value-based pricing, and more.
Topic Drug Pricing
Pink Sheet
By Ian Schofield 08 Apr 2021
The team behind Sputnik V has attacked what it calls “fake news and provocations” in the EU as political arguments over the vaccine claim another ministerial scalp.
Pink Sheet
By Brenda Sandburg 18 Mar 2021
Peter Marks says agency is getting first RWE readouts of vaccine safety; AstraZeneca’s vaccine has no expiration date, so stockpile is not currently at risk of being thrown out, the CBER director tells a House hearing.
Pink Sheet
26 Jan 2021
Stay informed of the latest news from the recent US election and understand how the shift in power will affect pharma regulatory and policy issues both within the United States and abroad. Pink Sheet takes you behind the US election headlines for analysis on the real impact you can expect to see on your business.
Topic US Election 2020
Pink Sheet
By Derrick Gingery 08 Dec 2020
As vaccines near availability, Moncef Slaoui says his full-time role at OWS may be ending. He has not met with the Biden Transition team, but notes that other Warp Speed officials have.
Pink Sheet
By Nielsen Hobbs 29 Nov 2020
Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.
Topic Coronavirus FDA
Pink Sheet
By Mandy Jackson 27 Nov 2020
Trump administration wants the HIV drug maker to license HHS patents related to pre-exposure prophylaxis. Lawsuit follows Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents.
Topic Infectious Diseases
Pink Sheet
By Bowman Cox 27 Nov 2020
Just as they did during the heparin crisis a decade ago, pharmaceutical companies must coordinate on coronavirus, Rx-360 CEO says.
Topic Manufacturing Vaccines Coronavirus
Pink Sheet
By Brenda Sandburg 27 Nov 2020
An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.
Topic FDA Policy & Regulation
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