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US Backs Oral COVID-19 Therapies And ‘Next Pandemic’ Drug Discovery With $3.2bn

Aiming to mimic public-private COVID-19 vaccine success, the US NIH will fund pandemic drug research, including taking candidates up to Phase II.

Companies Commercial Coronavirus COVID-19

Orphazyme Tumbles Back To Earth As FDA Rejects Arimoclomol

Following a week of "insane trading" which saw the Danish stock soar based on social media chatter, US regulators have surprised the firm and investors by issuing a complete response letter for arimoclomol for Niemann-Pick disease type C.

Complete Response Letters Rare Diseases Business Strategies

Should Global Pharmas Focus More On Korean Partners?

PharmaVentures’ Adrian Dawkes talks about how COVID-19 will impact pharma deals going forward and how Korean firms in particular may be able to grab opportunities in the global arena. 

South Korea Asia Pacific Deals

Coronavirus Spotlight

Does New Study Question Need for Pediatric COVID-19 Vaccines?

A recent study says a cohort of unvaccinated individuals aged under 16 years in Israel showed a nearly two-fold decrease in COVID-19 positivity for each 20 percentage points of individuals vaccinated overall. As Pfizer, Moderna and Bharat Biotech develop pediatric vaccines, should they consider if herd immunity might make such vaccines redundant?

Research & Development Coronavirus COVID-19

Rolling Coverage Of The Coronavirus Outbreak And The Biopharma Industry's Response Is Here.

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Pandemic Perspectives: 20-Plus Vaccines In Development As India Tackles COVID-19 Surge

From mRNA to subunit vaccines, Indian companies have 20 COVID-19 vaccine candidates, while three have already been approved. An August nod for Biological E could not just cut down time to immunize the country's population but also allow exports to resume.

India Coronavirus COVID-19

The 2021 Worldwide Pharma And Biotech R&D Scene

INFOGRAPHIC: A snapshot of the industry in key performance indicators surrounding R&D taken in early 2021.

Companies Market Intelligence

Pandemic Perspectives: China Vaccine Diplomacy - A World On Shots

Over 50 countries around the world are now receiving COVID-19 vaccine deliveries from China, totaling 3.3 million doses and counting so far. This Scrip infographic shows their locations, quantity of supplies and the developers involved.

China Coronavirus COVID-19

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BMS, Eisai Team Up To Accelerate Development Of Solid-Tumor ADC

The US firm gets development and co-commercial rights to MORAb-202 for $650m up front. BMS joins AstraZeneca, Merck & Co. and Gilead in recent ADC deal-making.

Deals Business Strategies

BIO 2021 Notebook: Best Practices For Business Development

The recently concluded BIO annual meeting included several sessions focused on the practice of business development. In this extra edition of our BIO 2021 notebook, Scrip collected observations about best practices for partnerships.

Business Strategies Commercial

Blueprint Prepares To Take On Novartis In Advanced Systemic Mastocytosis

The company’s rollout plans for Ayvakit appear similar to its approach when it marketed the drug for GIST, with an education plan to help boost sales.

Advertising, Marketing & Sales Business Strategies

Lupin’s US Advair Generic Plans Turn Awry As Celon Pact Nears End

Lupin’s plans for a US generic to GSK’s Advair Diskus have turned awry as its contract with Celon Pharma is close to being terminated. The company has focused on other respiratory drugs like generic ProAir and Fostair even as the revenue potential for Advair has been shrinking post Mylan’s launch.

Commercial Strategy

Biogen Gives Up On Gosuranemab After No Benefit Seen In Alzheimer's Study

Biogen’s investigational anti-tau antibody gosuranemab has missed its primary efficacy endpoint in a Phase II study in patients with Alzheimer's disease, prompting the end of the trial and termination of the compound’s further clinical development.

Clinical Trials Neurology

Apollo’s Next Steps: Apply Learnings From Prior Hub-And-Spoke Entities

Apollo’s $145m financing will help advance its 15-plus candidate portfolio into clinical development. With Patient Square leading the round, its expertise with BridgeBio and co. will help guide Apollo’s evolution.

Business Strategies Commercial
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BIO 2021 Notebook: Biogen CEO On Corporate Responsibility

News and views from day four of the BIO Digital annual meeting include the FDA's plans to use carrots not sticks to improve diversity and reflections on how the pandemic has strengthened biopharmaceutical supply chains. 

Clinical Trials Companies

BIO Notebook: Going Fast And Being Precise

News and views from day three of the BIO Digital annual meeting include Amgen’s CEO on speedy development and NIH’s chief on bringing personalized medicine to COVID vaccines.

Clinical Trials Drug Safety

BIO 2021 Notebook: A Breakthrough Year For Emerging Companies?

News and views from day two of the BIO Digital annual meeting include the increasing number of small companies driving US product approvals, the US FDA's Patrizia Cavazzoni on science vs. emotion at advisory committees and Merck & Co.'s Julie Gerberding on the need for continued HIV/AIDS research.

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Biogen Gives Up On Gosuranemab After No Benefit Seen In Alzheimer's Study

Biogen’s investigational anti-tau antibody gosuranemab has missed its primary efficacy endpoint in a Phase II study in patients with Alzheimer's disease, prompting the end of the trial and termination of the compound’s further clinical development.

Clinical Trials Neurology

Blow For CureVac As COVID-19 Vaccine Hits 47% Efficacy

CureVac is not throwing in the towel just yet, but the odds are stacked against a successful end result.

Coronavirus COVID-19 Research & Development

BIO Notebook: Going Fast And Being Precise

News and views from day three of the BIO Digital annual meeting include Amgen’s CEO on speedy development and NIH’s chief on bringing personalized medicine to COVID vaccines.

Clinical Trials Drug Safety
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