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Roche’s Port Delivery System Approved, Paving The Way For Ophthalmology Expansion

Susvimo, a PDS version of the blockbuster Lucentis, is a refillable eye implant that will extend Roche's commercial opportunity in wet-AMD but presents training challenges. Pricing is slightly below Lucentis.

Approvals Launches Ophthalmic

Sanofi Scores Clinical Win In Sixth Disease For Dupixent

The French major and partner Regeneron expect to file Dupixent for the rare skin disease next year after a Phase III trial of the blockbuster hit its primary and secondary endpoints.

Inflammation Clinical Trials Strategy

China Hits Two Billion COVID Jabs But More Effective mRNA Shots Elude

Despite administering a total of 2.2 billion COVID-19 shots, China as the first country to experience the coronavirus outbreak has yet to open its borders, while more effective mRNA vaccines are still nowhere to be found amid apparent delays for the licensed-in lead candidate.

China Coronavirus COVID-19 Vaccines

Coronavirus Spotlight

China Hits Two Billion COVID Jabs But More Effective mRNA Shots Elude

Despite administering a total of 2.2 billion COVID-19 shots, China as the first country to experience the coronavirus outbreak has yet to open its borders, while more effective mRNA vaccines are still nowhere to be found amid apparent delays for the licensed-in lead candidate.

China Coronavirus COVID-19

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

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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. 

Approvals Clinical Trials

Titans Of Pharma 2021: J&J’s Gorsky Tops Big Pharma Remuneration

INFOGRAPHIC: A snapshot of the compensation packages of CEOs and R&D leaders of the world’s biggest pharmaceutical companies, alongside median employee pay and key company performance metrics.

Leadership Strategy

Commercial Explore this Topic

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Latest From Commercial

Finance Watch: Four New IPOs Hold Steady In First Days Of Trading

Public Company Edition: Xilio, Ventyx, MiNK and Context went public in the US and later traded at or above their initial public offering prices. Also, Sarepta raised $500m and Relay grossed $350m in new offerings, while Oncopeptides, Esperion, Zymergen and Ardelyx reorganized and cut jobs.

Financing Business Strategies

High Stakes: Boehringer Faces Pre-Expiry India Jardiance Challenge

Indian firms debut empagliflozin copies ahead of expected patent expiry for diabetes blockbuster Jardiance in the country. Spotlight now on how swiftly Boehringer Ingelheim can fend off the entrants and whether the local challenge goes well beyond “inspiration” from the goings-on in the case of another SGLT2 inhibitor dapagliflozin.

Commercial Intellectual Property

Acceleron Investors Want Merck To Pay More, Ask Company To Wait For Better Offer

Avoro Capital, Holocene Advisors and Darwin Global say that Acceleron should sell later for a higher price based on forthcoming data or Merck should raise its bid above $180 per share.

Deals M & A

Deal Watch: J&J Partners On Bispecific Antibody R&D With F-Star, Xencor

Janssen Biotech adds to its bispecific antibody pipeline for cancer via pair of collaborations. Ipsen and Accent pair up to investigate new target for acute myeloid leukemia.

Deal Watch Business Strategies

Leucid Bio Unveils ‘Parallel CAR-T’ Platform Targeting Solid Tumors

The King's College London spin-out has gained £11.5m backing to take its ‘parallel CAR-T’ into the clinic.

Commercial Clinical Trials

Emerging Biopharma’s Next First Launch Market: China?

Despite multiple challenges including pricing pressures and slowing general economic growth, China offers attractive opportunities for emerging biopharma firms, helped by an encouraging regulatory environment. But weighing up options around challenging areas including partnering is essential, a new report states. 

China Commercial
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Policy & Regulation Explore this Topic

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Latest From Policy & Regulation

UCB Frustrated By FDA Failure To Inspect Facility For Psoriasis Drug

The Belgian group is the latest to be hit by the FDA's difficulties in address the growing backlog of facility inspections, leaving bimekizumab in limbo in the US, despite having just been approved as Bimzelx in Europe.

Drug Review Immune Disorders

GSK Shoulder-To-Shoulder With CureVac Over COVID-19 Vaccine U-Turn

The UK major is delighted with the German biotech's decision to throw in the regulatory towel with CVnCoV and concentrate on the firms' collaboration to development a second-generation COVID-19 vaccine. However, GSK is insisting that the partners look at both modified as well as unmodified mRNA approaches, a significant change of strategy for CureVac.

Vaccines Coronavirus COVID-19

Under The Shadow Of Drug Price Reform, US Tax Policies Still Challenge Pharma

Congress is considering legislation that would reverse some of the Trump administration's friendly corporate tax policies, presenting another challenge to the biopharmaceutical industry.

Politics Policy
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Research & Development

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Latest From Research & Development

Ocular’s Dry Eye Drug Fails In Phase II, But It Isn’t Giving Up Yet

Company hopes a different formulation of its intracanicular insert of cyclosporin might provide longer duration of drug in the eye and better tear production with it.

Clinical Trials Drug Approval Standards

Agenus PD-1 Down But Not Out With Cervical Cancer BLA Withdrawal

The company announced it would withdraw the BLA for balstilimab monotherapy in cervical cancer following Keytruda’s full approval, but it plans to keep developing the drug.

FDA ImmunoOncology

Pipeline Watch: Phase III Readouts In Breast And Liver Cancer Plus COVID-19

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals
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