Prescribed Reading: Cures for pharma funding

A weekly guide to the goings-on in the biopharma industry

Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.

In case you missed it

Mergers & analysis

AstraZeneca got investors riled up Friday morning, halting its stock trading early in the session. There was speculation the company would make some major announcement, such as potentially transformative M&A news.

Alas, investors got a major letdown when the company only announced that the Food and Drug Administration had accepted its Biologics License Application (BLA) for its PD-L1 inhibitor durvalumab for the treatment of bladder cancer. The British pharma is well behind competition in the space.

AstraZeneca did announce one collaboration Friday morning, though — a tie-up with Eli Lilly & Co to co-develop MEDI1814, an antibody selective for amyloid-beta 42 (Aβ42), for the treatment of Alzheimer's disease.

Despite Lilly's major setbacks in the space, the company has been unwavering in its dedication to finding a treatment for the debilitating neurodegenerative disease. AstraZeneca and Lilly are already paired on AZD3293, a BACE inhibitor in Phase 3 for the treatment of Alzheimer's disease.

Clinically relevant

Data poured out of the American Society of Hematology meeting last weekend, highlighting some of the most exciting types of therapies currently being developed and making ASH one of the biggest meetings of the year. Both Merck & Co and Bristol-Myers Squibb presented data from their respective PD-1 inhibitors in classical Hodgkin lymphoma. Both Keytruda (pembrolizumab) and Opdivo (nivolumab) have both been successful in solid tumors and the companies are also trying to be successful in hematological malignancies.

Meanwhile, competitors in the CAR-T space pushed forward despite setbacks in the space. Juno highlighted progress its making with JCAR017 as it tries to move beyond the deaths in recent trials of its lead candidate JCAR015.

Kite Therapeutics, on the other hand, continues to fly high as it preps to bring its CAR-T therapy to market, announcing over the weekend that it began its rolling Biologics Licensing Application.

Attention has now shifted from blood to the brain as scientists descend on the Clinical Trials on Alzheimer's Disease conference in San Diego where Eli Lilly & Co further clarified the failure of its amyloid plaque drug solanezumab. Investors are also taking a close look at the Phase 1b AD data from Biogen's aducanumab.

Highly regulated

After an overwhelmingly positive vote in the House of Representatives, the 21st Century Cures Act had an equally resounding yes vote in the Senate this week, sending the legislation to President Obama's desk to be one of the last bills he signs into law.

The Cures Act will provide $4.8 billion in new funding for the National Institutes of Health as well as the roughly $1 billion in grants to states to fight the opioid overdose epidemic.

While the industry views the bill as a positive, there has been some strong opposition in the form of senators Bernie Sanders and Elizabeth Warren.

While speculation continues about President-elect Donald Trump trying to repeal the Affordable Care Act once he comes to office, Sen. Bill Cassidy (R-LA) told attendees of a policy briefing at the Newseum this week that the approvals pathway created for biosimilars as part of Obamacare will likely not be affected even if the law is dismantled.

Off the bench

Industry continues to tap academia for innovation. This time, AbbVie is hooking up with the Robert H. Lurie Comprehensive Cancer Center of Northwestern University to advance research and discovery in oncology.

The company has been trying to broaden its pipeline as its best-selling drug Humira (adalimumab) faces biosimilar competition. The cancer center will have access to the company's preclinical research, while under the five-year agreement, AbbVie will have the right to license any discoveries made.

Collaborations in cancer have become a mainstay of the industry as big pharmas link up with biotechs and academia to find the right combinations to battle each variation of cancer. 

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Filed Under: Drug Discovery Clinical Trials Regulatory / Compliance