CHICAGO (Reuters) – Patients with advanced multiple myeloma treated with bluebird bio’s experimental immunotherapy lived for a median of nearly a year before their cancer worsened, according to data from a small study presented on Friday. The treatment, called... More »
COPENHAGEN (Reuters) – Shares in Danish biotech Genmab fell by as much as 25 percent on Monday after its partner Johnson & Johnson decided to ditch a study using its blockbuster cancer drug. Genmab said Janssen, a Johnson & Johnson business, had decided that t... More »
LONDON (Reuters) – Roche’s new hemophilia drug Hemlibra dramatically reduced bleeding in a broad population of hemophilia patients, results from two clinical trials showed on Monday, setting it up to take a dominant market position. Hemlibra cut by 96 percent ... More »
ZURICH (Reuters) – Roche’s immunotherapy combination that includes Tecentriq, Avastin and chemotherapy will get an accelerated review by U.S. regulators for use as an initial treatment of a common form of lung cancer, the Swiss drugmaker said on Monday. Roche ... More »
WASHINGTON (Reuters) – The U.S. Drug Enforcement Administration said on Friday it had suspended a Louisiana pharmaceutical distributor from selling controlled substances for allegedly selling unusually large quantities of opioids to pharmacies without reportin... More »
(Reuters) – Fourteen more people fell ill from an E. coli outbreak linked to romaine lettuce, U.S. health officials said on Friday, bringing the number of people affected to 98 across 22 U.S. states. The reported strain of E. coli, which produces poisonous sub... More »
(Reuters) – The U.S. Food and Drug Administration (FDA) on Monday slapped restrictions on the sale of Bayer AG’s implanted birth control device Essure, two years after the agency put a severe warning label on the product. The FDA said here some women were not ... More »
(Reuters) – GlaxoSmithKline has won a further reprieve for its blockbuster Advair lung drug after U.S. regulators insisted Hikma Pharmaceuticals conduct a further clinical study evaluating its generic version of the drug. The Jordan-based firm said on Monday i... More »
NEW YORK (Reuters) – Mylan NV on Wednesday struck a licensing agreement with Revance Therapeutics Inc to develop a biosimilar of Allergan Plc’s blockbuster Botox wrinkle treatment. The deal includes an upfront payment of $25 million to Revance, Mylan said. Re... More »
(Reuters) – A European Medicines Agency (EMA) panel on Friday recommended against approving Puma Biotechnology’s lead breast cancer drug, an outcome the U.S drugmaker had signaled last month. The EMA said the Committee for Medicinal Products for Human Use (CHM... More »
The logo of Gilead Sciences Inc is pictured during a news conference in New Delhi September 15, 2014. REUTERS/Anindito Mukherjee/File Photo (Reuters) – A federal judge in Delaware has overturned a jury’s verdict requiring Gilead Sciences Inc to pay a record $2... More »
FILE PHOTO: A sign is seen at an AstraZeneca site in Macclesfield, central England May 19, 2014. REUTERS/Phil Noble/File Photo LONDON (Reuters) – AstraZeneca’s immunotherapy drug Imfinzi has won crucial approval from U.S. regulators for use in lung cancer, ope... More »
FILE PHOTO: – A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo (Reuters) – The U.S. Food and Drug Administration on Friday declined to approve Apricus Biosciences In... More »
FILE PHOTO: – A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo (Reuters) – The U.S. Food and Drug Administration on Friday declined to approve Apricus Biosciences In... More »
FILE PHOTO – A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo (Reuters) – U.S. regulators have proposed lowering the bar for clinical trial success for experimental ... More »
(Reuters) – The U.S. Food and Drug Administration on Thursday approved a radioactive drug to treat the ultra-rare type of digestive tract cancer that killed Steve Jobs in 2011. The approval for Advanced Accelerator Applications SA’s Lutathera comes just days a... More »
The chairman of Swiss pharmaceutical company Roche, Christoph Franz speaks to media after the annual general meeting in Basel March 4, 2014. REUTERS/Ruben Sprich ZURICH (Reuters) – Fears U.S. President Donald Trump could damage the drugs industry have not been... More »
FILE PHOTO: A man poses for a photograph while using a Philip Morris iQOS smoking device, in Bogota, Colombia November 14, 2017. REUTERS/Jaime Saldarriaga/File Photo WASHINGTON (Reuters) – Philip Morris International Inc should not be allowed to claim its iQOS... More »
FILE PHOTO: A man uses a Philip Morris iQOS e-cigarette in Tokyo, Japan May 12, 2017. REUTERS/Issei Kato/File Photo WASHINGTON (Reuters) – In a decision expected to test the Trump administration’s approach to tobacco regulation, U.S. health advisers will vote ... More »
SAN FRANCISCO (Reuters) – Global drugmakers are looking to a tiny biotech’s $850,000 therapy for a rare type of blindness as a model for getting paid for highly expensive – and effective – new medicines. Spark Therapeutics Inc plans to launch its recently appr... More »
The logo of Swiss pharmaceutical company Roche is seen outside their headquarters in Basel, January 30, 2014. To match special report USA-FDA/CASES REUTERS/Ruben Sprich/File Photo ZURICH (Reuters) – The European Union approved Roche’s multiple sclerosis medici... More »
FILE PHOTO: Swiss drugmaker Novartis’ logo is seen at the company’s plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann ZURICH (Reuters) – The U.S. Food and Drug Administration has granted priority review for Novartis... More »
Vials of MPC-150-IM, Mesoblast’s stem cell product, are seen in this undated handout photo received December 14, 2017. Mesoblast/Handout via REUTERS NEW YORK (Reuters) – The early hope that stem cell therapy would make the paralyzed walk, the blind see and cur... More »
(Reuters) – Aclaris Therapeutics Inc’s drug to treat a common kind of skin growth called seborrheic keratoses received approval from the U.S. Food and Drug Administration, the company said on Friday. It is the only topical medicine for the condition to receive... More »
(Reuters) – The U.S. Food and Drug Administration has allowed Alnylam Pharmaceuticals Inc to restart clinical trials on a drug to treat patients with a rare bleeding disorder, the company said on Friday. All ongoing studies of the drug, fitusiran, had been pla... More »
(Reuters) – Drug developer Sage Therapeutics Inc’s shares soared as much as 85 percent to a record high on Thursday after its experimental drug to reduce the symptoms of depression succeeded in a mid-stage trial. Sage’s shares were up 73 percent at $159, on tr... More »
FILE PHOTO – U.S. Administrator of the Centers for Medicare and Medicaid Services (CMS) Seema Verma (C) is joined by Concerned Women for America CEO Penny Nance (L) as she talks to reporters about President Trump’s signing of House Resolution 43, which allows ... More »
(Reuters) – Indivior’s experimental drug to help fight America’s growing opioid addiction crisis was approved by the U.S. Food and Drug Administration late on Thursday, boosting its sales prospects as competitors threaten revenues from an older product. Shares... More »
FILE PHOTO: The logo of AstraZeneca is seen on medication packages in a pharmacy in London April 28, 2014. REUTERS/Stefan Wermuth/File Photo LONDON (Reuters) – Drugmaker AstraZeneca plans to turbo-charge its already substantial Chinese business through a new d... More »
Dynavax Technologies Corp's hepatitis B vaccine won the U.S. Food and Drug Administration's approval on the third attempt and Chief Executive Eddie Gray told Reuters the company was open to, but not waiting for, a partner to market the drug. More »
Eagle Pharmaceuticals Inc said on Friday the U.S. Food and Drug Administration tentatively approved its diluted version of Eli Lilly and Co's blockbuster cancer drug Alimta. More »
Endo International Plc said two units filed a lawsuit on Thursday accusing the U.S. Food and Drug Administration of ignoring key components of a law passed after a deadly 2012 meningitis outbreak linked to a compounding pharmacy. More »
GlaxoSmithKline's gene therapy for the so-called "bubble boy" disease was approved by Britain's healthcare cost watchdog NICE, despite a price tag of almost 600,000 euros ($700,000). More »
GlaxoSmithKline has won U.S. approval for a new and improved shingles vaccine, the second of three key products for which the British drugmaker expects approval this year. More »
Novartis on Monday said the U.S. Food and Drug Administration has granted breakthrough therapy status to the combination of Tafinlar and Mekinist to treat patients with BRAF V600-positive stage III melanoma following surgery. More »
Regeneron Pharmaceuticals Inc and Sanofi SA said on Monday their drug to treat inflammation in the esophagus, mainly caused by food allergies, met the main goal of a mid-stage study. More »
Exelixis Inc's drug to treat a type of liver cancer improved overall survival in patients in a late-stage study that prompted an independent expert group to recommend no further trial, sending the company's shares soaring 31 percent. More »
Spark Therapeutics Inc's experimental gene therapy for a rare form of blindness improves vision and should be approved, advisers to the Food and Drug Administration concluded on Thursday, paving the way for the first U.S. gene therapy for an inherited disease. More »
The Trump Administration threw its support behind a public-private partnership with 11 drug companies to advance a new class of drugs that uses the body's immune system to fight cancer. More »
Flexion Therapeutics Inc said its injectable drug to treat osteoarthritis-related knee pain was approved by the U.S. Food and Drug Administration, sending the drug developer's shares soaring to a record high in regular trading on Friday. More »
The U.S. Food and Drug Administration on Monday announced a series of measures designed to speed to market generic versions of complex drugs such as Mylan NV's emergency EpiPen in an effort to address the rising cost of pharmaceuticals. More »
The U.S. Food and Drug Administration said on Thursday it approved an Eli Lilly and Co drug to treat advanced breast cancer that has progressed following prior treatment. More »
PTC Therapeutics Inc's experimental drug to treat Duchenne muscular dystrophy, a devastating degenerative disease that mostly affects young boys, may work but the company will need to do more work to prove it, an advisory panel to the U.S. Food and Drug Admini... More »
Roche immunotherapy Tecentriq has won European Union approval for treating advanced lung and bladder cancer, the Swiss drugmaker said. More »
The U.S. Food and Drug Administration has declined to approve Johnson & Johnson's rheumatoid arthritis drug sirukumab, saying additional clinical data is needed to further evaluate its safety, the company said on Friday. More »
A Native American tribe holding patents for drugmaker Allergan Plc (AGN.N) on Friday moved to dismiss a case brought by generic drug company Mylan NV (MYL.O) challenging the patents. More »
The head of the U.S. Food and Drug Administration said on Friday the agency is working on a new policy that would encourage more compounding pharmacies to register under a law enacted in the wake of a deadly 2012 meningitis outbreak linked to one such company. More »
U.S. Senator Sherrod Brown said on Friday a deal that drugmaker Allergan Plc made with a Native-American tribe to shield patents "rips off consumers" and cannot "become the new normal." More »
Swiss drugmaker Novartis notched a trial win for its drug cocktail against skin cancer on Monday, while a rival treatment from Roche with slipping sales failed in a separate study with a similar patient group. More »
The British government has rekindled its industrial strategy, unveiled earlier this year to prepare the economy for Brexit, with plans to boost the country's pharmaceuticals sector via fresh investments and public-private collaborations. More »
Novo Nordisk said on Friday the U.S. Food and Drug Administration (FDA) approved an expanded use of its diabetes drug to reduce the risk of cardiovascular events such as heart attack and stroke. More »
Shares in Vernalis fell more than 15 percent on Monday as the British biotech company backed by fund manager Neil Woodford and his previous employer Invesco announced a fresh setback for a key new drug in the United States. More »
The U.S. Drug Enforcement Administration (DEA) on Friday proposed a 20 percent reduction in the manufacture of certain commonly prescribed opioid painkillers as well as other controlled substances for next year. More »
FILE PHOTO: The logo of AstraZeneca is seen on medication packages in a pharmacy in London April 28, 2014. AstraZeneca said on Tuesday that U.S. regulators had awarded its blood cancer drug acalabrutinib “breakthrough” status for the treatment of patients with... More »
The U.S. Centers for Medicare & Medicaid Services (CMS) said on Tuesday it had approved Alaska’s proposal to stabilize its state health insurance exchange by creating a program to cover claims by people with certain high cost conditions. More »
Endo International Plc said on Thursday it agreed to withdraw its long-acting opioid painkiller Opana ER from the market after the U.S. Food and Drug Administration declared its benefit did not outweigh public health risks associated with opioid abuse. More »
Cancer deaths in America’s rural areas are not falling as much as they are in urban areas even though the total deaths from the disease are dropping across the country, a U.S health agency report showed, emphasizing the gap in access to healthcare. More »
Martin Shkreli, former chief executive officer of Turing Pharmaceuticals and KaloBios Pharmaceuticals Inc, departs after a hearing at U.S. Federal Court in Brooklyn, New York, U.S., June 26, 2017. REUTERS/Lucas Jackson Federal prosecutors on Monday asked a U.S... More »
A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed The U.S. Food and Drug Administration on Friday approved a new oral blood-thinner made by Portola Pharmaceuticals Inc to preven... More »
A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo The U.S. Food & Drug Administration on Tuesday delayed indefinitely implementation of a new nutrition facts label th... More »
Fertility clinic Miracle IVF Center is seen in Vientiane, Laos June 7, 2017. REUTERS/Phoonsab Thevongsa Dozens of fertility clinics have mushroomed in land-locked Laos after scandals over commercial surrogacy have spurred wealthier southeast Asian neighbors to... More »
AbbVie Inc said on Wednesday its oral rheumatoid arthritis drug succeeded in a late-stage study on patients who had not adequately responded to standard treatments. More »
FILE PHOTO – A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo The U.S. Food and Drug Administration on Monday approved Edwards Lifesciences Corp’s Sapien 3 artificia... More »
FILE PHOTO – A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo The number of new drugs approved for sale in United States and Europe has bounced back this year, sugge... More »
The logo of Swiss pharmaceutical company Roche is seen outside their headquarters in Basel, January 30, 2014. REUTERS/Ruben Sprich/File Photo A person in Germany treated with Roche Holding AG’s new multiple sclerosis drug Ocrevus has been diagnosed with an oft... More »
GW Pharmaceuticals is set to file its cannabis-derived drug with U.S. regulators imminently, following publication of detailed data on its success in fighting severe childhood epilepsy. More »
Puma Biotechnology Inc’s experimental breast cancer drug reduces the risk of disease recurrence and should be approved, an advisory committee to the U.S. Food and Drug Administration concluded on Wednesday. More »
Hikma Pharmaceuticals said on Thursday that U.S. regulators had decided not to approve its generic copy of GlaxoSmithKline’s blockbuster lung drug Advair at this time, due to ‘major’ issues with its application. More »
A view of the Merck & Co. campus in Linden, New Jersey March 9, 2009, after Merck & Co Inc said it would acquire Schering-Plough Corp in $41.1 billion deal, widening Merck’s pipeline and diversifying its portfolio of medicines. REUTERS/Jeff Zelevansky Merck & ... More »
Pharmaceutical companies called on Thursday for a phased transition in drug regulation after Britain leaves the European Union, in order to avoid supply disruption and protect public health. More »
A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo Merck & Co’s cholesterol-reducing drug Vytorin faces competition for the first time ever after two companies announc... More »
Guido Rasi, executive director the European Medicines Agency (EMA), poses for a portrait at his office in London, Britain, January 6, 2012. REUTERS/Finbarr O’Reilly/File Photo Europe’s drugmakers pushed for a decision as early as June on the new location for t... More »
A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo South Korea’s Samsung Bioepis Co Ltd said on Saturday the U.S. Food and Drug Administration approved its copy of Joh... More »
U.S. President Donald Trump smiles after signing S.544, the Veterans Choice Program Extension and Improvement Act, at the White House in Washington, U.S., April 19, 2017. REUTERS/Kevin Lamarque President Donald Trump on Wednesday moved a step closer to fulfill... More »
An Abbott company logo is pictured at the reception of its office in Mumbai, India, September 8, 2015. REUTERS/Shailesh Andrade The U.S. Food and Drug Administration issued a warning letter to Abbott Laboratories, citing manufacturing flaws with a range of car... More »
FILE PHOTO: A DNA double helix is seen in an undated artist’s illustration released by the National Human Genome Research Institute to Reuters on May 15, 2012. REUTERS/National Human Genome Research Institute/Handout/File Photo The University of California is ... More »
The U.S. Food and Drug Administration approved Neurocrine Biosciences Inc’s drug to treat tardive dyskinesia, a side effect of antipsychotic medications characterized by uncontrolled movements of the face and body, the company said. More »
Dr. Scott Gottlieb testifies before a Senate Health Education Labor and Pension Committee confirmation hearing on his nomination to be commissioner of the Food and Drug Administration on Capitol Hill in Washington, D.C., U.S. April 5, 2017. REUTERS/Aaron P. Be... More »
FILE PHOTO: A Marlboro cigarettes pack, a brand of Philip Morris Tobacco, lies next to an empty coffee cup at a cafe in central Sydney June 27, 2011. REUTERS/Daniel Munoz/File Photo Philip Morris International said on Friday it has applied for pre-market appro... More »
EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers are seen in Washington, U.S. August 24, 2016. REUTERS/Jim Bourg/File Photo Generic drugmaker Mylan NV said on Friday that its manufacturi... More »
The GlaxoSmithKline building is pictured in Hounslow, west London June 18, 2013. REUTERS/Luke MacGregor/File Photo Mylan NV said on Wednesday the U.S. Food and Drug Administration declined to approve its generic version of GlaxoSmithKline Plc’s (GSK.L) blockbu... More »
Dr. Scott Gottlieb is seen in this American Enterprise Institute photo released in Washington, DC, U.S., March 10, 2017. Courtesy The American Enterprise Institute/Handout via REUTERS Dr. Scott Gottlieb, President Donald Trump’s nominee to lead the U.S. Food a... More »
U.S. health regulators on Thursday approved a drug developed by Merck KGaA and Pfizer Inc that helps the immune system to fight a rare form of skin cancer once it has spread to other parts of the body. More »
A man talks on the phone near a sign for the reception office of China’s Food and Drug Administration in Beijing, China, May 17, 2016. REUTERS/Damir Sagolj China is considering taking measures that will shorten the time to market for approved imported drugs in... More »
The House Budget Committee begins the markup of the American Healthcare Act on Capitol Hill in Washington, U.S., March 16, 2017. REUTERS/Joshua Roberts Deeply divided Republicans squeezed their U.S. healthcare overhaul, backed by President Donald Trump, throug... More »
Developers of an experimental blood test for autism say it can detect the condition in more than 96 percent of cases and do so across a broad spectrum of patients, potentially allowing for earlier diagnosis, according to a study released on Thursday. More »
Merck & Co Inc said on Tuesday it had got a nod from the U.S. Food and Drug Administration for its already-approved immunotherapy drug Keytruda as a treatment for a type of blood cancer. More »
Dr. Scott Gottlieb is seen in this American Enterprise Institute photo released in Washington, DC, U.S., March 10, 2017. Courtesy The American Enterprise Institute/Handout via REUTERS U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a conservative he... More »
FILE PHOTO — A general view of the Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Georgia September 30, 2014. REUTERS/Tami Chappell/File Photo The U.S. Centers for Disease Control and Prevention (CDC) is investigating a multistate ou... More »
FILE PHOTO – The federal government forms for applying for health coverage are seen at a rally held by supporters of the Affordable Care Act, widely referred to as ”Obamacare”, outside the Jackson-Hinds Comprehensive Health Center in Jackson, Mississippi, U.S.... More »
The U.S. Food and Drug Administration said on Tuesday it had approved Lexicon Pharmaceuticals Inc’s oral drug to treat carcinoid syndrome diarrhea, a condition that develops in patients with gastrointestinal tumors. More »
FILE PHOTO – The Pfizer logo is seen at their world headquarters in Manhattan, New York, U.S., August 1, 2016. REUTERS/Andrew Kelly/File Photo The U.S. Food and Drug Administration said Pfizer Inc’s process for manufacturing sterile injectable drugs at a plant... More »
The logo of Swiss drugmaker Novartis AG is seen at its headquarters in Basel, Switzerland January 25, 2017. REUTERS/Arnd Wiegmann Swiss drugmaker Novartis’s drugs Tafinlar and Mekinist edged closer to approval in Europe to be used together against a type of lu... More »
Shelves displaying medicines are seen at a pharmacy in Shanghai, China November 27, 2015. REUTERS/Aly Song/File Photo China has updated list of medicines covered by basic medical insurance schemes, a long-awaited fillip for drugmakers in the world’s second-lar... More »
The U.S. Justice Department has joined a whistleblower lawsuit against UnitedHealth Group Inc that claims the country’s largest health insurer and its units and affiliates overcharged Medicare hundreds of millions of dollars, a law firm representing the whistl... More »
A U.S. appeals court on Thursday struck down a Florida law that barred doctors from asking patients about gun ownership, ruling that the law violated doctors’ right to free speech. More »
FILE PHOTO – The federal government forms for applying for health coverage are seen at a rally held by supporters of the Affordable Care Act, widely referred to as ”Obamacare”, outside the Jackson-Hinds Comprehensive Health Center in Jackson, Mississippi, U.S.... More »
U.S. President Donald Trump gestures as he leaves the podium after a news conference at the White House in Washington, U.S., February 16, 2017. REUTERS/Kevin Lamarque U.S. President Donald Trump’s choice to lead an important health agency said on Thursday that... More »
FILE PHOTO: Packets of Herceptin sit on a pharmacy shelf in London, Britiain, June 9, 2006. REUTERS/Luke MacGregor/File Photo Treatment with two important cancer drugs is about to get much cheaper in Europe with a cut-price copy of Roche’s blood cancer drug Ri... More »
FILE PHOTO – The federal government forms for applying for health coverage are seen at a rally held by supporters of the Affordable Care Act, widely referred to as ”Obamacare”, outside the Jackson-Hinds Comprehensive Health Center in Jackson, Mississippi, U.S.... More »
