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Pharma Heads Hope Trust Built Through Pandemic With Policymakers Will Last

The bosses of Bayer and Roche's pharmaceutical divisions – Stefan Oelrich and Bill Anderson – have called on governments in Europe to create a friendlier environment so that the sector and policymakers can continue to work better together post-pandemic.

Market Access Europe Business Strategies

Merck's Gefapixant CRL Dashes Hopes For Another Near-Term Growth Driver

The US FDA issued a complete response letter for the P2X3 receptor antagonist for the treatment of refractory chronic cough, requesting more efficacy data.

Complete Response Letters FDA Commercial

Stock Watch: Biogen, Blood In The Water

When almost everything that could go wrong has gone wrong at a company, the proposition of it turning acquirer may meet with some resistance from its proposed targets and their investors.

Stock Watch M & A Companies

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Scorching COVID-19 Era Returns From India Biotech, Healthcare Funds Outpace The Globe

Early COVID-19 therapies including Gilead’s remdesivir, China-plus procurement policies, vaccine partnerships and a dovish stance by the central bank led to returns on India biotech and healthcare funds outperforming global returns. Meanwhile, funding for e-pharmacies and online consulting firms gathered pace.

Commercial Financing

Breast Cancer Trial Enrollment Illustrates Diversity Challenge

INFOGRAPHIC: Data on industry-sponsored breast cancer studies posted on ClinicalTrials.gov shows how much work remains for drug makers to ensure their studies enroll diverse populations.

Diversity & Inclusion Clinical Trials

Alzheimer’s Disease: Many Failures Before One Success

For Biogen/Eisai’s success with Aduhelm, there were 93 failures in the anti-amyloid field. Scrip took a look back at how the pipeline for amyloid-targeting Alzheimer’s drugs progressed over roughly the past decade to showcase exactly how difficult the Alzheimer’s space has been. 

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$140m Cash Boost For Leyden Labs Anti-Flu Nasal Spray

The Dutch biotech has signed off a sizeable series B fundraising to take its intranasal products to fight current and future viral outbreaks into the clinic.

Financing Infectious Diseases

Onward Ho: Biocon Signals Glargine Build Up, US Biosimilars Pricing ‘Sanity’

Biocon anticipates significant US uptake of its Viatris-partnered interchangeable insulin glargine biosimilar on the back of commercial arrangements in place and expects to "move the market" in 2022.  All eyes are also on the trajectory of biosimilar insulin aspart, which received a CRL from the US FDA.

Commercial Biosimilars

Mirati Spies ‘First-In-Class’ Chance For KRAS Inhibitor In Pancreatic Cancer

While chasing Amgen’s Lumakras in NSCLC, Mirati looks to now have an edge in two other tumor types.

Companies Commercial

Lupin’s Foncoo Partnership Beginning Of China Challenge To AZ, Cipla?

Lupin’s partnership with Shenzhen Foncoo marks the Indian firm's much-awaited entry into China. Will this and more planned alliances make Lupin a worthy respiratory challenger to AstraZeneca, compatriot Cipla and others in a country where chronic respiratory diseases are the second leading cause of death?

China Deals

Coronavirus Update: Generics And Hurdles For Molnupiravir, More Japan Approvals

More generic deals but also US approval hurdles for Merck's oral antiviral, while Japan approves more options and Valneva's vaccine candidate shows promise against Omicron. 

Coronavirus COVID-19 Vaccines

Can Novo’s Oral Semaglutide Shake Up Indian Diabetes Segment?

Novo Nordisk's oral semaglutide debuts in India at a monthly cost of about $135 and promises to transform diabetes management in the country. Will it impact the SGLT-2 inhibitor class and potentially cannibalize injectable GLP-1 receptor agonists?

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Pfizer And AbbVie JAKs Finally Join Dupixent In US Atopic Dermatitis Space

The arrival on the US eczema market of a couple of oral JAK inhibitors with stellar data on itching could provide a challenge to Sanofi and Regeneron's blockbuster Dupixent. However, Pfizer and AbbVie will have to overcome dermatologists' fears about the class-effect safety warnings their drugs come with.

Approvals Dermatology

A Deep Dive Into The Game-Changing Drugs For Skin Diseases

Scrip's Kevin Grogan joins Datamonitor's Pamela Spicer and Davinderpreet Mangat to discuss the skin disease landscape and whether atopic dermatitis is now where psoriasis was a decade ago as another wave of innovative products start to reach the market.

Approvals Dermatology

Lilly Braces For Impact Of CMS Draft Coverage Decision On Biogen’s Aduhelm

The draft national coverage determination, released shortly before Lilly CEO David Ricks spoke at the J.P. Morgan Healthcare Conference, said Medicare will cover anti-amyloid antibodies only for patients in clinical trials, severely limiting commercial potential for Biogen’s Aduhelm and near-term competitors.

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Research & Development

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Cellino Raises $80m Series A To Transform Stem Cell Therapy Manufacturing

The Cambridge, MA start-up aims to ‘democratize’ therapies based on induced pluripotent stem cells by developing an automated manufacturing system.

Biologics Companies

Could Faricimab Data Help Roche Maintain Ophthalmic Market Foothold?

The company published data for the bispecific antibody in wet AMD and DME, with non-inferior efficacy to Eylea and growing support for less frequent administration.

Ophthalmic Biologics

Sanofi Pairs Up With Non-Profit Protas In Quest To Cut Clinical Trial Costs

The French major has committed up to £5m for non-profit Protas, which aims to facilitate large clinical studies at a fraction of the usual price and form more pharmaceutical collaborations down the line.

Clinical Trials Cost Effectiveness
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