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.

In a wilderness period for biotech stocks, platform company revenues may offer investors less volatile biotech exposure. They are unlikely to shepherd an exit from the current doldrums, though.

Public Company Edition: Cancer-focused Adlai Nortye launched a concurrent initial public offering and private placement, while four other drug developers announced or completed SPAC mergers. Also, Sobi grossed $540m in a rights issue and Immunovant followed early data with a $450m FOPO.

With positive results from a Phase II proof of concept controlled human infection model study evaluating Neumifil under its belt, the Scottish biotech is preparing to put the drug through its paces in a chronic obstructive pulmonary disease trial next year.

Armed with an old drug and new data, the group is aiming to revitalize the smoking cessation market. 

The ex-chief medical officer at Novartis is now CEO at the UK-based biotech, which he he told Scrip could have a ‘transformational’ therapy to protect patients after a heart attack.

Ampersand Biomedicines has emerged from stealth mode with a new CEO, and aims to shake up oncology and immunology with a new tissue-specific approach to targeting medicines.

Among the newer modalities to tackle cancer, antibody-drug conjugates are fast emerging to rival targeted antibodies and China is fast emerging as a world class source of innovation in the field, as evidenced by a string of recent deals.

After a multi-year lull, NASH R&D has picked up this past year with key data readouts, several programs advancing toward Phase III and Madrigal's resmetirom under FDA review with a March 2024 action. This graphic provides a look at the overall status of NASH drug R&D.

The Merck & Co vaccine for human papillomavirus Gardasil, along with Johnson & Johnson’s Darzalex for multiple myeloma, entered the ranks of the top 10 best-selling drugs globally in the second quarter. There was no product for COVID-19 in the line-up for the first time since 2020.

An infographic looking at commercial factors for the 10 drugs chosen for Medicare price negotiation in 2026 under the Inflation Reduction Act (IRA). The graphics below review the valuations of these drugs, both past and forecast, as well as their relative contributions to the top-lines of the companies that own them.

The withdrawal of the targeted anticancer comes as no surprise after its Phase III missed in July, but it sets back Takeda’s expansion plans in the competitive therapy area.

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.

Drug manufacturers will have to participate in the Medicare drug price negotiation process for the foreseeable future. Judge Newman's finding that participation in Medicare is voluntary could defeat constitutional challenges to the program and have an impact on other cases. 

Japan's latest batch of product approvals includes high-profile Alzheimer's drug Leqembi (lecanemab), along with Alhemo (concizumab) for hemophilia, Phozevel (tenapanor) for hyperphosphatemia and others. Eyes are now on the shape of use guidelines and monitoring requirements for Leqembi, along with how its extended NHI  reimbursement pricing process will develop. All going well, it could reach the market by the end of the year.

In this week's podcast edition of Five Must-Know Things: major Q4 catalysts; Verona’s COPD contender; Alfasigma acquires Intercept; more setbacks for Keytruda/Lenvima combo; and new pressures on China IPOs.

The AUGMENT-101 study showed a strong response rate among acute leukemia patients who historically have a poor prognosis.

The drug price assessment group ran cost analyses on two of the first 10 drugs selected for Medicare price negotiations, Eliquis and Xarelto, and submitted the report to the US government.

A Phase III hit is always nice but a lot more information will be required to judge iptacopan’s market potential.

In a wilderness period for biotech stocks, platform company revenues may offer investors less volatile biotech exposure. They are unlikely to shepherd an exit from the current doldrums, though.

With positive results from a Phase II proof of concept controlled human infection model study evaluating Neumifil under its belt, the Scottish biotech is preparing to put the drug through its paces in a chronic obstructive pulmonary disease trial next year.

Life sciences firms are increasingly adopting new technologies like the metaverse and piloting use cases, although a "truly 3D immersive customer experience" may be some distance away. But 2024 could see an inflection point with increasing demand for certain metaverse applications, says a senior Indegene executive.