FDA approves Gilead's once-daily combination pill for suppressed HIV patients
The US Food and Drug Administration has approved Gilead Sciences' (GILD) Bixlenvo, a once-daily oral combination pill for adults whose HIV infection has already been suppressed to very low levels, the company said.
Kimberly-Clark seeks EU approval for $40bn Kenvue acquisition
Kimberly-Clark (KMB) has filed for European Union regulatory approval of its proposed $40 billion acquisition of Kenvue (KVUE), according to documents published on the European Commission's website.
Eli Lilly to acquire Merida Biosciences for up to $2.88bn in autoimmune push
Eli Lilly (LLY) has agreed to acquire privately held Merida Biosciences for up to $2.88bn in cash, bolstering its immunology pipeline with an experimental treatment for thyroid-related autoimmune conditions as the company accelerates its push beyond weight-loss drugs.
BridgeBio's Attruby shows evidence of disease reversal in long-term heart study
BridgeBio Pharma (BBIO) has presented new analyses from its phase 3 ATTRibute-CM study of Attruby (acoramidis) in transthyretin amyloid cardiomyopathy, including the first evidence from serial cardiac magnetic resonance imaging that a therapy may be capable of reversing disease progression, at the European Society of Cardiology Congress 2026.
Novartis pauses eight clinical trials of experimental cell therapy after three patient deaths
Novartis (NVS) has suspended eight clinical trials of its experimental cell therapy rap-cel, which targets autoimmune and neurological disorders, after three patients died following a severe immune reaction, the Swiss drugmaker disclosed.
Jazz's Ziihera records second survival win in HER2-positive stomach cancer
Jazz Pharmaceuticals (JAZZ) has secured a second overall survival victory for its bispecific antibody Ziihera in HER2-positive gastroesophageal adenocarcinoma, strengthening the drug's case as the preferred treatment backbone in a condition affecting roughly 8,000 Americans annually.
Florida sues PBMs over alleged pharmacy price-fixing scheme
Florida's attorney general has filed suit against pharmacy benefit managers Express Scripts, a unit of Cigna (CI), and Prime Therapeutics, accusing the rival drug middlemen of engaging in illegal price-fixing that has gutted reimbursements to the state's pharmacies and threatened patient access to medications.
Pharma giants double down on AI in race to slash drug development costs
Pharmaceutical companies have sharply accelerated their embrace of artificial intelligence, striking a wave of partnerships and acquisitions since the start of 2025 as they seek to compress drug development timelines and reduce costs through automation and advanced molecular modelling.
Guardant Health ordered to pay $245mn in DNA sequencing patent dispute
A US federal court has ordered Guardant Health (GH) to pay more than $245.2mn to TwinStrand Biosciences and the University of Washington after finding the cancer diagnostics company had infringed patents covering DNA sequencing technology.
Argenx soars on trial success as Europe's biotech champion mounts record-breaking rally
Argenx SE (ARGX) has staged one of Europe's most striking biotech rallies in recent memory. The company’s dramatic gains last month have propelled the Belgian biotech’s market capitalization to €55.4bn ($64.8bn), overtaking Moderna (MRNA), whose own market value has more than doubled over the same period following its own dramatic run.
FDA Approves Gilead's Once-Daily Combination Pill for Suppressed HIV Patients
The US Food and Drug Administration has approved Gilead Sciences' (GILD) once-daily oral combination pill for the treatment of adults whose HIV infection has already been reduced to undetectable levels, the California-based drugmaker said.
Kimberly-Clark Seeks EU Clearance for $40bn Kenvue Acquisition
Kimberly-Clark (KMB) has filed for European Union regulatory approval of its proposed $40bn acquisition of Kenvue (KVUE), according to documents published on the European Commission's website, as the consumer goods company advances its most ambitious deal in years.
White House strikes second round of 'most favored nation' drug pricing deals with nine mid-sized pharmaceutical companies
The Trump administration has unveiled a second wave of drug pricing agreements under its most favored nation, or MFN, policy framework, this time securing deals with nine mid-sized pharmaceutical companies including Alcon (ALC), Astellas Pharma (ALPMY), BeOne Medicines (ONC), BridgeBio (BBIO), CSL, Kyowa Kirin (4151), Sun Pharma (SUNPHARMA), Teva Pharmaceuticals (TEVA) and UCB (UCB).
Alnylam cuts full-year sales forecast as post-launch TTR drug momentum fades
Alnylam Pharmaceuticals (ALNY) has lowered its full-year 2026 sales guidance by approximately $200mn, blaming slower-than-expected growth in its transthyretin, or TTR, amyloidosis franchise after initial launch demand normalized — a disclosure that sent the company's shares tumbling more than 28 per cent.
Celon Pharma's generic semaglutide matches Ozempic in early trial, sending shares surging
Celon Pharma (CLNP) said its experimental semaglutide product Reduzek demonstrated comparable absorption to Novo Nordisk's (NVO) Ozempic and Wegovy in an early-stage bioequivalence study, sending shares in the Polish drugmaker up 14.7 per cent — on course for their best single-day gain since July 2024.
FDA clears Roche and Eli Lilly's blood test for Alzheimer's detection
The US Food and Drug Administration has cleared a blood test developed by Roche (RHHBY) and Eli Lilly (LLY) to help identify signs of Alzheimer's disease in patients aged 55 and older experiencing cognitive decline, marking another step in the industry's push to make diagnosis simpler and more accessible.
Eli Lilly launches oral weight-loss pill Foundayo in the UK
Eli Lilly (LLY) has launched Foundayo, its oral weight-loss and diabetes treatment, in the United Kingdom, making Britain the first country in Europe where the pill is available following regulatory approval earlier this month.
EU regulators cite data manipulation in Tavneos market withdrawal
European regulators have laid out in greater detail the concerns underpinning their decision to strip the rare disease drug Tavneos of its marketing authorization in the European Union, alleging serious breaches of clinical trial protocol that they say fundamentally undermine the evidence base supporting the complement inhibitor.
Pfizer grapples with post-Covid hangover as debt and doubts mount
In the private dining room of a San Francisco steakhouse in January, Albert Bourla cut a confident figure. The Pfizer (PFE) chief executive joked with reporters as he fielded questions about his company and the broader pharmaceutical landscape, his mood seemingly untouched by the pressures bearing down on the drugmaker he has led since 2019.
Karyopharm Faces Default as Cash Reserves Dwindle to Four-Week Runway
Karyopharm Therapeutics (KPTI) is racing to secure financing or a lender waiver before a $15.8mn loan payment falls due on September 10, after a deepening second-quarter loss left the company with just $65.4mn in cash and a runway extending only into next month.