To view this email as a web page, click here

Subscribe

Advertise

 

 

 

 

 

 

July 26, 2019

Roche’s troika of blockbuster cancer drugs has dominated for years, with Rituxan, Herceptin and Avastin collecting over $10 billion in combined U.S. sales last year alone. But those days may be numbered, at least for the latter two, as Amgen and Allergan launch competing biosimilars this week—both at 15% off the list price. Meanwhile, Pfizer’s top-selling Lyrica has sailed off the patent cliff, opening the door to copycats from no less than 10 drugmakers looking to chip away at its share, which brought in $3.6 billion in 2018 U.S. sales. But the silver lining, according to CEO Albert Bourla, is that Lyrica is Pfizer’s main expiration until 2026, giving it time to establish successors. Those stories and more made up our top reads this week.

Featured Story

Roche doomsday is here: Long-feared Herceptin, Avastin biosims bust into U.S. market

For years, Roche’s blockbuster oncology troika—Rituxan, Herceptin and Avastin—dominated sales stateside and abroad. For two drugs in that superstar trio, those landmark years could be approaching an end.

Top Stories Of The Week

GSK drops lung injury drugs as respiratory clear-out continues

GlaxoSmithKline has terminated 11 projects over the past 12 months. The respiratory franchise bore the brunt of the cuts at a time when some GSK staff were questioning the wisdom of investing in the field.

Pfizer's keys to juggling 8 U.S. launches? Organization, accountability, clear goals

Think you’re busy? Take a look at Pfizer’s commercial team for oncology, which is currently launching four new drugs, three new indications for older drugs, and a biosimilar. And that’s just in the U.S.

Lyrica generics roll: Pfizer blockbuster finally hits patent cliff

Pfizer's Lyrica has had a long, multibillion-dollar run. But now, that megablockbuster history is nearing its end. A slew of generics won FDA approval Friday, and they're revving up to race for the U.S. market.

A personalized CAR-T to attack every solid tumor? Pact Pharma has a plan

Startup Pact Pharma and UCLA researchers presented new data on a technology the company developed to define specific cancer mutations in each individual patient and then manufacture an immune-cell therapy that targets abnormal proteins.

Celgene drops $2.6B Jounce pact, bags rights to macrophage drug

Celgene has restructured its alliance with Jounce, dropping the $2.6 billion pact it formed in 2016 while securing full rights to a single asset. The changes cut Celgene’s ties to programs that overlap with those in Bristol-Myers Squibb’s portfolio.

Among recent megamergers, only AbbVie-Allergan looks like a winner: analyst

SVB Leerink was one of the few Wall Street firms to praise AbbVie's planned $63 billion acquisition of Allergan. Now the analysts are explaining why they like the deal, and it all boils down to diversification.

IBM Watson Health's new manager talks about returning to basics, doubling down

Former Ciox Health CEO Paul Roma has been installed as the new general manager of IBM's Watson Health unit with plans to refocus the project’s efforts on where it's seen success.

Novartis licenses out early antiviral work to Gilead

Just two days after announcing its R&D chief was stepping down, Gilead Sciences has announced it will be buying up a few of Novartis’ unwanted early-stage infection assets.

Biohaven suckerpunched by CRL tied to Apotex warning letter

The sting of the FDA slapping Apotex with a warning letter has been felt by a U.S. biotech which used an API from the cited facility in a bioequivalence study.

Resources

[Whitepaper] The Truth about Physician Referrals and Clinical Trials

The Study Voices survey challenges the myth that physicians won’t refer patients to clinical trials, and it identifies opportunities to engage physicians as partners in the enrollment process.

[eBook] Small molecules 2.0: the bigger picture

The highest number of NCEs approved by the FDA…the fastest growing small molecule clinical pipeline reported in 20 years…these are exciting times for our industry.

[Paid Marketplace] Faster Research. Smarter Bibliographies.

Cut your research time in half - with an easy-to-use app for scientists that combines full-featured reference management with integrated search and on-demand document delivery.

[Video] Almac Launches Almac Adapt™ - a New Patient-Centric Supply Solution

Innovative Just in Time Manufacturing solution enables sponsors full late stage customisation of clinical trial materials

[Video] PwC Webcast: Goodbye cost shifting, hello employer activism

How are employer activism strategies beginning to replace the cost-sharing of the past, and improve the health of the workforce?

[Whitepaper] Transforming the future of medical shipments

The combination of SAVSU technology with United Airlines’ global network has made it easier than ever to bring cell and gene therapies to destinations beyond major markets.

[Whitepaper] IoT Technologies & Informatics Integration in Pharmaceuticals

Find out in this article how your pharmaceutical organization can leverage IoT technologies and informatics integration to innovate and improve overall operational efficiencies.

[Whitepaper] Managing Demand Uncertainty in Biologics Production

When a biologics company prepares to launch a new product, it must forecast the manufacturing capacity it will need. Learn more here.

[Report] NEW Report on 2019 e-Prescribing Regulations and Potential Impact

Patient demand for more information on their care is driving new e-prescribing regulations, and technology is evolving to help providers meet them. This report provides an overview of key areas where such regulation has emerged, and what it could mean for providers and healthcare IT companies.

[Whitepaper] Characterizing Drug Substance Properties Early Can Optimize Drug Product Formulation

Anticipate challenges in formulation early.

[Whitepaper] Managing Comorbidities in Type 2 Diabetes – Real World Evidence for Change

Patients living with diabetes deserve better – Real-World Evidence for effecting/realizing change in the management of type 2 diabetes and cardiovascular/renal comorbidities.

[Case Study] Clinical Supply Management

Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study.

[Video] Demand Led Services and Clinical Supply Efficiency

Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels.

[eBook] Strategies for Efficient Clinical Supply Management and Forecasting

Download the eBook to explore a proactive approach for clinical supply management.