Cytokinetics’ Phase III Data Position Myqorzo To Treat Full HCM Patient Spectrum
Topline data in the Phase III ACACIA-HCM study bring Cytokinetics’ Myqorzo success in non-obstructive HCM, a patient base in which Bristol’s Camzyos failed a Phase III trial.
Scrip - May 5, 2026

Viridian’s Subcutaneous TED Treatment Passes Second Phase III Test
The company will file for US FDA approval of elegrobart in thyroid eye disease in Q1 of 2027. The anti-IGF-1R antibody previously reduced proptosis in active TED and now in chronic TED.
Scrip - May 5, 2026

J&J Moves JNJ-4804 Into Phase III Despite Mixed Efficacy Results
The drugmaker presented data from the Phase IIb DUET studies of the drug versus Simponi and Tremfya at Digestive Disease Week.
Scrip - May 5, 2026

Pfizer’s Post-2029 Growth Outlook Brighter Thanks To Vyndamax LOE Delay
Delayed generic entry of Vyndamax boosts Pfizer’s confidence in its long-term financial outlook and cash flow, including the ability to maintain a dividend and invest in BD.
Scrip - May 5, 2026

Cytospire Raises $83m To Develop ‘Pan Gamma Delta’ T Cell Engagers
The UK biotech has developed a platform which it believes can overcome shortcomings in previous technologies and challenge CD3-based T cell engagers.
Scrip - May 5, 2026

Stock Watch: Novartis Stumbles, GSK Falls Harder
After patent cliffs, big pharma revenue becomes a tension between products losing exclusivity and new drugs replacing them. In Novartis’s first quarter, the offsetting fell short. Perhaps the only consolation was that GSK’s results the next day were received even less favorably by investors.
Scrip - May 5, 2026

BioMarin Leans On Acquisition-Led Expansion As Pipeline Readouts Near
Upcoming quarters are expected to provide clearer insight into how BioMarin’s expanded portfolio and late-stage pipeline translate into growth.
Scrip - May 5, 2026

Vertex Thinks Renal Franchise Could Be Its Next Cystic Fibrosis Moment
Vertex executives expressed strong optimism about the company's nascent renal franchise even as they reported an mRNA therapy discontinuation and mixed revenue results.
Scrip - May 5, 2026

How AI Helped Leo Pharma Track Down Replay
Leo Pharma CEO Christophe Bourdon and Replay CEO Lacklan MacKinnon explain how the Danish firm used a combination of old school networking and technology to contact the under-the-radar gene therapy specialist.
Scrip - May 5, 2026

Proposed Rule Would Replace ‘Gender’ With ‘Sex’ In US FDA Regulations
The move appears to be another step in the Trump Administration’s diversity, equity and inclusion purge that already has impacted FDA guidances and webpages.
Medtech Insight - May 5, 2026

‘The Planets Start to Line Up’: AAMI on the Growing Consensus Around Medtech AI Standards
Standards organization AAMI is finding renewed buy-in from regulators, tech firms and physicians as the need for AI standards becomes more pressing. With broad guidelines already taking shape, the group believes in-depth standards for specific AI use cases are next on the block.
Medtech Insight - May 5, 2026

Medtronic Faces Class Action Over Breach of Nine Million Patient Records
A federal class action complaint filed in Minnesota alleges that the medical device giant failed to protect sensitive patient data, exposing millions to identity theft and financial harm.
Medtech Insight - May 5, 2026

How A Cigarette Legal Battle Could Change AI Medtech Regulation
An EU Court of Justice ruling means standards medtech companies must follow under the AI Act could be free to access.
Medtech Insight - May 5, 2026

Lack Of Growth Troubles German IVD Sector
Confidence in the prospects for Germany’s in vitro diagnostics businesses has dipped to its lowest level since the VDGH industry association began surveying market sentiment. The IVDR and lower reimbursement are part of the problem. The industry says it’s time for action.
Medtech Insight - May 5, 2026

FDA Updates Medical Device Charging Guide With Warning Against Liquid Spillage
The agency's revised guidance comes amid various recalls tied to overheating and electrical failures in home medical devices.
Medtech Insight - May 5, 2026

IVL Competition Heats Up As Medtech Giants Circle The Market
Stryker, Boston Scientific, Abbott, and others are piling into intravascular lithotripsy (IVL), a market that J&J now dominates through Shockwave, as the market for cracking arterial calcium is shaping up to be anything but a one-company show.
Medtech Insight - May 5, 2026

Church & Dwight Sees Inflation Pressuring Consumers, But Higher Costs Could Trigger Pricing
“We have no plans to try to price through” a $25m to $30m headwind from costs and inflation, says CEO Richard Dierker. But it grows to $50 million to $150 million, “who knows where it stops, then you have to solve a different problem with different solutions.”
HBW Insight - May 6, 2026

Ravicti Rivals Follow End Of Par Exclusivity In US
Multiple new generic versions of Ravicti (glycerol phenylbutyrate) have now been approved in the US, following Par’s first generic launch and Lupin’s launch of an authorized generic in October.
Generics Bulletin - May 5, 2026

Lannett Delivers On US Insulin Glargine Approval
After a long time in development, Lannett’s HEC-partnered insulin glargine biosimilar has finally made it to approval in the US. With the firm's acquisition by Aurobindo still pending, Lannett has set out plans to create a new Lanexa Biologics subsidiary to market its biosimilars.
Generics Bulletin - May 5, 2026

‘We Need To Get It Over The Finish Line’ – Biosimilars Forum’s Reed On The Red Tape Elimination Act
Time is running out for the US Congress to pass the Biosimilar Red Tape Elimination Act and enshrine changes to the country’s interchangeability regime in formal legislation. Julie Reed, executive director of the US Biosimilars Forum, explains why the move is so urgently needed.
Generics Bulletin - May 5, 2026

The Wisdom Behind Life Sciences M&A&D Strategies
McKinsey & Co partner Bart Van de Vyver adds insight to dealmaking and growth trends as the firm releases its latest assessment of what’s driving strategic decision-making at the top end of the healthcare products industries.
In Vivo - May 5, 2026

How A Nonprofit Ecosystem Is Rescuing Orphaned Cell And Gene Therapies
Nonprofit alliances led by Telethon, ASGCT and OTXL are building new infrastructure to rescue abandoned “commercially pre?viable” cell and gene therapies.
In Vivo - May 5, 2026