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Pharma Q3 Results Preview: Merck Vs. Bristol In IO Showdown

With Merck and Bristol-Myers Squibb at the head of the immuno-oncology class – and jockeying for the lead – the two companies are reporting third quarter earnings in back-to-back calls on Oct. 25. Oncology has become dominant for both businesses, and analysts are keen for nuances to help differentiate the growth potential for the two firms.

Sales & Earnings Cancer Business Strategies

Roche Remains Positive After Tecentriq Triple-Negative Breast Cancer Data

Clinicians and the company have heralded the IMpassion130 data presented at ESMO which showed that Roche's Tecentriq is the first immunotherapy to improve outcomes in TNBC but a slight blot on the landscape is that pretty much all of the survival benefit was seen in breast cancer patients with PD-L1 positive tumors.

Cancer ImmunoOncology Clinical Trials

Clovis In Pole Position To Be First PARP For Prostate Cancer

Clovis is looking a steal a march on its rival PARP inhibitors and hopes to be the first drug in the class to get approval for prostate cancer following strong data seen in the TRITON trial.

Research & Development Clinical Trials Cancer
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Induced Pluripotent Stem Cells Help Eisai's Hunt For Novel Parkinson's Leads

As part of broader efforts to pursue novel approaches to common neurological disorders, Eisai uses iPSC-derived cells to help identify potential new drug therapies for Parkinson's.

Japan Research & Development Research and Development Strategies

Pharma Q3 Results Preview: Biogen, Gilead, Celgene

Ozanimod re-filing is a big near-term catalyst for Celgene. Biogen investors will be looking for more information about the development and regulatory strategy for BAN2401 in Alzheimer's. And Gilead investors want reassurance that the company will return to growth soon. 

Sales & Earnings Business Strategies Research and Development Strategies

Finance Watch: Investment In Novel Antibacterials Gets A New Boost With Qpex Launch

Repeat antibiotic entrepreneurs raised $33m to launch Qpex with assets from The Medicines Co. Also, Taiho increases VC fund to $300m and TP Therapeutics raises $80m.

Financing StartUps and SMEs

Lupin Gears For Europe Specialty Push With Orphan NaMuscla

Lupin’s rare disease drug, NaMuscla, has been recommended for marketing authorization in Europe – a key milestone for the firm as it shapes its play in the specialty segment. The company may consider taking NaMuscla to other markets such as Japan as well and also add assets to its neuroscience portfolio.

Commercial Strategy

Dupixent Approved For Severe Asthma With Broader Label Than Other Biologics

The US FDA cleared Sanofi/Regeneron's IL-4/IL-13 inhibitor for moderate-to-severe asthma in patients with an eosinophilic phenotype or with oral corticosteroid-dependent asthma, a broader label than AstraZeneca's Fasenra, GSK's Nucala and Teva's Cinqair.

Approvals Respiratory

Deal Watch, Licensing & Alliances: Amgen Places $66m Bet On Genetic Sequencing

Already partnered with Oxford Nanopore through its acquisition of deCODE Genetics, Amgen invests in the UK biotech to enhance its genomic capabilities. Aclaris licenses dermatology product Rhofade from Allergan. Other recent licensing and alliance deals... 

Deals Business Strategies

Deal Watch, M&A: Warp Drive And Its Partnerships Acquired By Revolution

Once expected to be absorbed by Sanofi, US biotech Warp Drive Bio now will become part of California’s Revolution Medicines in a stock transaction. Sosei elects against its option to acquire MiNA Therapeutics; MeiraGTX follows its June IPO with takeout of Vector Neurosciences. Other recent mergers and acquisitions... 

M & A Deals

Every Little Helps: Shire Product Advances Fortify Takeda's Bid

A positive opinion in the EU for Shire's Takhzyro and a favorable US advisory committee vote for prucalopride are incremental positives for Takeda's planned acquisition, on which shareholders are likely to vote in the coming weeks.

Advisory Committees Approvals

Policy & Regulation Explore this Topic

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Anatomy Of A Biotech Company: Acorda Gets Dressed For A Second Act

Acorda's rise, fall, and attempt to rise again is a snapshot of the life of a biotech. The company reached the commercial-stage pinnacle with Ampyra, only to eventually see it fall away to patent challenges. Now, after big staff cuts, the company is hoping to prevail in the commercial market again, this time with Inbrija.

Leadership Companies Intellectual Property

Every Little Helps: Shire Product Advances Fortify Takeda's Bid

A positive opinion in the EU for Shire's Takhzyro and a favorable US advisory committee vote for prucalopride are incremental positives for Takeda's planned acquisition, on which shareholders are likely to vote in the coming weeks.

Advisory Committees Approvals

Pfizer Expands In Breast Cancer With Talazoparib Approval

The PARP inhibitor, acquired with Medivation, will launch in a field where Pfizer already has commercial experience through its CDK4/6 inhibitor Ibrance. 
Approvals Launches

Vertex’s Danish Reimbursement Deal Brings Budget Predictability

Vertex’s portfolio-based access deal in Denmark will give patients quicker access to a range of cystic fibrosis drugs and give budget predictability to the company and government.

Europe Denmark

Research & Development Explore this Topic

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Roche's Tecentriq Positive But Not Perfect In IMpower130 First-line Lung Cancer Study

Combination with Abraxane demonstrates an overall survival benefit on top of progression-free survival, but Merck's competing Keytruda has set a high benchmark for first-line metastatic lung cancer.

ImmunoOncology Clinical Trials Market Intelligence

Pipeline Watch: Top-Line Phase III Results For Satralizumab, Lemborexant And Dupilumab

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events 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

Stellar Survival Data For AZ's Lynparza Hailed At ESMO

Clinicians and analysts have lauded spectacular results presented at ESMO from the SOLO-1 trial which strongly suggest that AstraZeneca's Lynparza should be the first-line maintenance treatment of choice for ovarian cancer patients with a BRCA mutation.

Cancer Clinical Trials

AbbVie Buys In On Morphic’s Oral Integrin Inhibitors, To Tune Of $100m

After years of industry unsuccessfully trying to find an oral version of the successful I.V. integrin inhibitors, Morphic has a prolific platform – and AbbVie is paying $100m up front for preclinical oral integrin inhibitors for fibrosis indications, potentially including NASH.

Deals Liver & Hepatic
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