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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

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 M & A

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 Business Strategies
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Case Study: Broad Thinking Yields Big Results

There are numerous details when considering product packaging that require both creative thinking and feature prioritization. Rather than developing a standard solution for the current need, it’s imperative to think broadly and design options that are cost-effective, simplify operations and save time and/or resources.

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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 Commercial

A Long March After Approval: What You Need To Launch Orphan Drugs In China

Without automatic reimbursement in place, makers of orphan and rare disease drugs must look at innovative alternative ways to make their high-priced new therapies accessible to patients in China.

China Business Strategies Commercial

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

CDMO Space In Focus As Piramal Mulls Sale

As the Indian business conglomerate Piramal considers the sale of its contract development and manufacturing organization (CDMO), some experts say that more CDMO players could potentially join the sale line up in a fragmented sector but one that’s in demand.
Commercial Deals

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

Eight Things To Know From Novartis' Third Quarter Call

The company's $2.1bn acquisition of Endocyte and expansion into radiopharmaceuticals dominated some of the call, but with the launches of drugs like Cosentyx, Kymriah, Kisqali and Aimovig underway, there was a lot for Novartis' management team to address.

Sales & Earnings Launches

Medivir Clears The Decks For Clinical Focus, Cuts All Preclinical Projects

Medivir outlines plans to cut costs, reduce headcount and streamline priorities as the biotech focuses solely on four assets in clinical development.

Companies Commercial

Novartis Tunes Into Radiopharmaceuticals With Endocyte Buy

Endocyte paid just $12m upfront a year ago for a potential first-in-class investigational radioligand therapy for prostate cancer. Novartis is buying Endocyte for a whopping $2.1bn., highlighting the company's emphasis on building in radiopharmaceuticals.

M & A Cancer

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

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

Industry Makes A Drug Price Transparency Push In DTC Ads, But Is It Too Little Too Late?

PhRMA unveiled a voluntary policy under which drug makers will provide information in DTC ads about how to access drug prices and cost information. But hours later HHS issued a proposed rule on the same topic, only requiring drug makers to include WAC prices in TV ads. .

Pricing Debate Advertising, Marketing & Sales

Research & Development Explore this Topic

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Merck & Co.’s Keytruda/Inlyta Combo Invades Kidney Cancer Territory

Merck & Co.’s IO powerhouse Keytruda has trumped Bavencio’s recent Inlyta combo PFS win in kidney cancer, with a OS and PFS combo hit of its own. But the field is getting increasingly crowded. 

ImmunoOncology Clinical Trials Commercial

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

UCB Pushes On With Potential Myasthenia Gravis Therapy, But Competition Looms

The anti-FcRn MAb, rozanolixizumab, has been found to be effective in myasthenia gravis and has potential in ITP, but other companies are also developing potential therapeutic candidates for such auto-immune conditions.

 

Neurology Clinical Trials

Teva Stands By Migraine Strategy After Ajovy Misses Boat On Express Scripts Deal

Agreement between Amgen/Novartis and Eli Lilly with Express Scripts on new migraine drugs could spur more demand by payers for simple, value-based outcomes deals.

Pricing Strategies Reimbursement
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