Roche opens door to generic production of Xofluza in developing world
ROCHE (RHHBY) has agreed to allow generic manufacturers to produce its influenza antiviral baloxavir marboxil, signing a voluntary licence with the Medicines Patent Pool in a move that could significantly expand access to the drug across the developing world.
BioMarin ($BMRN) rare disease drug missed key Phase 3 goal, raising approval concerns
BioMarin Pharmaceutical reported mixed Phase 3 results for experimental rare disease therapy BMN 401, raising uncertainty around the drug’s regulatory prospects and adding pressure to the company’s efforts to diversify its revenue base.
Novartis ($NOVN.S) terminated Porton manufacturing deal and warned of potential $64m legal claims
Novartis terminated a manufacturing and facility leasing agreement with Chinese CDMO Porton Pharma Solutions following a dispute tied to regulatory issues at a production site in Slovenia.
AstraZeneca (AZN.L) secured FDA approval for blood pressure drug Baxfendy
AstraZeneca received U.S. approval for hypertension treatment Baxfendy, giving the drugmaker a new entrant into the large and highly competitive cardiovascular market.
The therapy, also known as baxdrostat, was approved for use alongside existing blood pressure medications in patients with uncontrolled hypertension.
US Supreme Court rejected pharma industry challenge to Medicare drug pricing law
The U.S. Supreme Court declined to hear a pharmaceutical industry challenge against the Biden-era Medicare drug price negotiation programme, leaving in place lower court rulings that upheld the policy under the Inflation Reduction Act.
Merck (NYSE: MRK) uterine cancer drug met late-stage goals, boosting investor focus on ADC pipeline
Merck & Co. said its experimental cancer therapy sacituzumab tirumotecan (sac-TMT) improved survival and delayed disease progression in patients with advanced or recurrent endometrial cancer in a late-stage trial.
Eli Lilly claims double crown in pharma R&D rankings
Eli Lilly (LLY) has claimed top position in both principal categories of a prominent annual ranking of pharmaceutical research and development performance, the first time a single company has achieved the feat since the index was established.
White House expands drug pricing portal with 600 generic medicines
The White House has added more than 600 generic medicines to TrumpRx.gov, its government-run drug price comparison portal, in an attempt to address a significant gap in the platform's coverage since its launch earlier this year.
WHO rushes supplies to Congo as Ebola outbreak spreads amid deepening uncertainty
The World Health Organization is racing to contain a growing Ebola outbreak in the Democratic Republic of Congo, with a further six tonnes of medical supplies due to land on Tuesday as international health officials acknowledged significant uncertainty over the scale of the crisis.
Angelini strikes $4.1bn deal for Catalyst Pharma in state-backed US push
Angelini Pharma has agreed to acquire Florida-based Catalyst Pharmaceuticals (CPRX) for $4.1bn, marking the Italian group's debut in the US pharmaceutical market and the second significant American acquisition by an Italian drugmaker in as many weeks.
BridgeBio presses challenge to Pfizer in ATTR-CM after data hint at survival edge
BridgeBio Pharma has presented late-stage data suggesting its transthyretin amyloidosis drug Attruby could gain an edge over Pfizer's tafamidis franchise in ATTR-CM, a closely watched rare heart-disease market.
Mankind Pharma posts 30% profit rise on chronic therapies demand
Mankind Pharma (MNKI.NS) reported a sharp rise in quarterly profit on Tuesday, buoyed by robust demand for chronic therapies and consumer healthcare products, as the Indian drugmaker outpaced broader market growth at home even as rivals struggled with deteriorating conditions in the United States.
Sanofi deepens rare disease push with diagnostic and treatment partnerships
Sanofi [SNY] is stepping up its commitment to rare disease through two distinct partnerships, as the French pharmaceutical group seeks to strengthen its specialty care franchise and improve outcomes for patients with underdiagnosed conditions.
Novo Nordisk heart drug disappoints in key trial
Novo Nordisk [NVO] suffered a setback to its drug pipeline on Tuesday after a treatment at the centre of a major acquisition produced disappointing results in a clinical trial for heart failure patients.
Jazz Pharmaceuticals confounds sceptics with strong Q1 print, but valuation now leaves little room for error
Jazz Pharmaceuticals, the Dublin-headquartered drugmaker, has delivered a markedly stronger first-quarter performance than analysts had anticipated, capping a twelve-month period in which the stock has more than doubled — and prompting a fresh debate over whether the equity now offers meaningful upside or has caught up with the underlying fundamentals.
Algeria and Hungary deepen pharmaceutical ties in latest sign of Algiers' industrial outreach
Algeria has opened talks with Hungary on expanding bilateral cooperation in pharmaceutical manufacturing and clinical research, in the latest sign of the North African country's continuing push to attract foreign technical expertise into one of its more strategically prioritised industrial sectors.
Rocket Pharmaceuticals stretches cash runway as priority review voucher sale offsets clinical setbacks
Rocket Pharmaceuticals, the US gene therapy specialist, has bought itself an additional two years of operational runway through the $180mn sale of a regulatory voucher, easing pressure on a balance sheet that had been narrowing as the New Jersey-based group navigated a difficult phase of pipeline development and corporate restructuring.
aTyr Pharma (NASDAQ: ATYR) shares fell after company outlined revised Phase 3 trial strategy
aTyr Pharma shares declined sharply after the company announced plans for a new Phase 3 study of efzofitimod in pulmonary sarcoidosis following discussions with the U.S. Food and Drug Administration.
Brano Therapeutics secured $6.8m seed funding to advance heart failure pipeline
Brano Therapeutics raised $6.8 million in seed financing to support the development of new therapies targeting heart failure, including Heart Failure with preserved Ejection Fraction (HFpEF), an area where treatment options remain limited.
Zealand Pharma (CPH: ZEAL) shares rose after obesity pipeline progress and Roche-linked outlook boost
Zealand Pharma shares climbed after the company reported positive clinical progress across its obesity pipeline and strengthened its financial outlook with expected milestone payments from partner Roche.