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#Biotechnology and Medical Research (TRBC)

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U.S. approves first marijuana plant-derived drug for epilepsy

(Reuters) – The U.S. health regulator approved GW Pharmaceuticals Plc’s epilepsy treatment on Monday, making it the first cannabis-based drug to win approval in the country and opening floodgates for more research into the medicinal properties of cannabis. The... More »

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Merrimack to scrap development of pancreatic cancer treatment

(Reuters) – Merrimack Pharmaceuticals Inc said on Monday it would stop developing its experimental treatment for pancreatic cancer after it failed to meet the main and secondary goals in a mid-stage trial. The company said it would now focus on developing othe... More »

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Mixed results for Bristol/Nektar combination in cancer trial

Chicago (Reuters) – Mixed results over the weekend from closely watched studies combining Bristol-Myers Squibb Co’s cancer immunotherapy with Nektar Therapeutics experimental drug NKTR-214, led at least one Wall Street analyst to reassess expectations. Bristol... More »

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FDA wants to shorten new drug monopolies to cut costs

CHICAGO (Reuters) – In an effort to increase competition and bring down prescription drug prices, FDA Commissioner Dr. Scott Gottlieb wants to speed approval times for rivals to promising new first-to-market medicines. The U.S. Food and Drug Administration chi... More »

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Merck’s Keytruda extends lung cancer survival in two trials

CHICAGO (Reuters) – Merck & Co’s immunotherapy Keytruda improved survival as a stand-alone treatment for newly-diagnosed lung cancer patients and with chemotherapy for hard-to-treat squamous cell lung cancer, new data released on Sunday showed, further cementi... More »

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FDA chief outlines new ways to speed cancer drug approvals

CHICAGO (Reuters) – The U.S. Food and Drug Administration is taking steps to streamline the approval process for cancer drugs, reviewing clinical trial data up front to make sure applications companies submit are complete. The new approach, outlined on Saturda... More »

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Roche drugs show limited benefit in lung, breast cancer trials

CHICAGO (Reuters) – In a disappointment for Roche Holding AG (ROG.S), two of its oncology drugs provided only modest protection from disease progression in lung cancer and breast cancer, according to data from separate clinical trials presented on Saturday. Ad... More »

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Loxo Oncology posts improved results for newest cancer drug

CHICAGO (Reuters) – An experimental cancer drug from Loxo Oncology performed even better in patients with a rare mutation of the RET gene than previously reported, according to updated results from an early stage clinical trial presented on Saturday. Last mont... More »

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Gene sequencing study finds new cancers linked with Lynch syndrome

CHICAGO (Reuters) – Lynch syndrome, a rare hereditary disease typically associated with an increased risk of colorectal and endometrial cancers, appears to be linked with several additional types of cancer than previously thought, U.S. researchers said on Satu... More »

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Bluebird myeloma treatment delays cancer progression: trial

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 »

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Danish biotech Genmab hit by ending of trial using key cancer drug

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 »

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U.S. joins whistleblower case against Insys over kickbacks

(Reuters) – The U.S. Department of Justice has joined whistleblower litigation accusing Insys Therapeutics Inc of trying to generate more profit by paying kickbacks to doctors to prescribe powerful opioid medications. The government’s involvement was disclosed... More »

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U.S. to consider expanding Medicare drug price negotiation

WASHINGTON/NEW YORK (Reuters) – The Trump administration is considering expanding Medicare’s ability to negotiate the cost of drugs by giving private payers a role in setting the price of medicines administered in hospitals and doctors’ offices, Health and Hum... More »

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FDA chief questions protections on drug rebates, stocks fall

(Reuters) – U.S. Food and Drug Administration chief Scott Gottlieb on Thursday questioned whether rebates that drugmakers provide to health insurers should remain protected by federal law, sparking new concerns on Wall Street over efforts to curb drug pricing.... More »

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Scientists devise new, more accurate peanut allergy test

LONDON (Reuters) – British scientists have developed a far more accurate blood test to diagnose peanut allergy, offering a better way to monitor a significant food hazard. Peanuts are the most common cause of fatal food-induced anaphylaxis, or severe allergic ... More »

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Too many cancer drugs? Crowded market gives investors pause

LONDON (Reuters) – In London’s world-famous Great Ormond Street children’s hospital, Dr. Karin Straathof is excited about a new cell-based medicine that offers hope for toddlers with incurable nerve tissue cancer. Her progress with a handful of children for wh... More »

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Vertex Pharma profit tops estimates on strong launch of new CF drug

(Reuters) – Vertex Pharmaceuticals Inc topped analysts’ forecasts for quarterly profit on Thursday, led by stronger-than expected sales of its latest cystic fibrosis drug as well as double-digit growth in sales of older treatments. Boston-based Vertex, like ot... More »

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AbbVie’s beat fueled by demand for Humira, Hep C drugs

(Reuters) – AbbVie Inc reported a better-than-expected quarterly profit on Thursday, on higher sales of its rheumatoid arthritis treatment Humira and its Hepatitis C drugs, leading the company to raise its full-year earnings forecast. The company’s shares, whi... More »

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GE rides gene therapy wave with ready-made viral drug factories

LONDON (Reuters) – General Electric is raising its bet on biotechnology with the launch of prefabricated manufacturing units for producing virus-based gene and cell therapies, novel anti-cancer treatments and vaccines. Interest in such medicines, which use eng... More »

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GSK slims portfolio with sale of rare disease gene therapy drugs

LONDON (Reuters) – GlaxoSmithKline is divesting its rare disease gene therapy drugs to private biotech company Orchard Therapeutics as Chief Executive Emma Walmsley makes good on her promise to prune the drugmaker’s pharmaceuticals portfolio. Financially, the ... More »

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Few Americans aware of cancer drug shortages

(Reuters Health) – Most Americans aren’t aware of cancer drug shortages that might lead some patients to receive less effective or more toxic treatments, a U.S. study suggests. In a nationally representative survey of 420 adults, just 16 percent said they knew... More »

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U.S. investors retreat from stock funds for third week: Lipper

NEW YORK (Reuters) – U.S. fund investors pulled back from the stock market for a third straight week, withdrawing $11.6 billion in cash in the week ended Wednesday, in the face of a potential full-blown trade war between the United States and China, Lipper dat... More »

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Pfizer’s rare heart disease drug succeeds in late-stage study

(Reuters) – Pfizer Inc’s experimental drug to treat a rare and fatal disease linked to heart failure reduced deaths and need for hospitalizations in a late-stage study. The company’s clinical study investigated the efficacy, safety and tolerability of an oral ... More »

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Mylan teams up with Revance on biosimilar for Botox

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 »

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KemPharm’s opioid painkiller gets FDA approval, shares soar

(Reuters) – KemPharm Inc said on Friday the U.S. Food and Drug Administration approved its opioid painkiller Apadaz for the short-term management of acute pain, sending the shares of the drugmaker up as much as 36 percent in late afternoon trading. The company... More »

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Shares of Apricus tank after FDA declines to OK erectile…

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 »

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Apricus says FDA declines to approve erectile dysfunction cream

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 »

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Pot Pharm: Booming Canada weed sector plots next-wave medicines

A worker collects cuttings from a marijuana plant at the Canopy Growth Corporation facility in Smiths Falls, Ontario, Canada, January 4, 2018. REUTERS/Chris Wattie TORONTO (Reuters) – Canopy Growth Corp, one of the world’s biggest medical marijuana producers, ... More »

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U.S. FDA looks to pave way for earlier-stage Alzheimer’s drugs

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 »

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New York accuses Insys of deceptively marketing opioid

FILE PHOTO: A box of the Fentanyl-based drug Subsys, made by Insys Therapeutics Inc, appears in an undated photograph provided by the U.S. Attorney’s Office for the Southern District of Alabama. U.S. Attorney’s Office for the Southern District of Alabama/Hando... More »

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AstraZeneca is sued by Array BioPharma over cancer drug royalties

NEW YORK (Reuters) – Array BioPharma Inc on Thursday sued AstraZeneca AB, accusing the pharmaceutical company of refusing to pay required royalties for a cancer drug after entering into an $8.5 billion collaboration with Merck & Co. In a complaint filed in the... More »

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U.S. SEC files suit over possible insider trading on Bioverativ

FILE PHOTO: The seal of the U.S. Securities and Exchange Commission hangs on the wall at SEC headquarters in Washington, DC, U.S., June 24, 2011. REUTERS/Jonathan Ernst/File Photo (Reuters) – The U.S. Securities and Exchange Commission filed an insider trading... More »

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U.S. tech stock funds attract most cash since 2000: Lipper

NEW YORK (Reuters) – U.S. technology stock funds took in more cash in the week ended Jan. 24 than in any week since the turn-of-the-century bubble, Lipper said on Thursday, offering further evidence that investors’ wariness about markets has given way to exube... More »

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Chinese scientists break key barrier by cloning monkeys

Zhong Zhong and Hua Hua, two cloned long tailed macaque monkeys are seen at the Non-Primate facility at the Chinese Academy of Sciences in Shanghai, China January 10, 2018. Picture taken January 10, 2018. Qiang Sun and Mu-ming Poo, Chinese Academy of Sciences ... More »

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Sanofi to buy U.S. haemophilia group Bioverativ for $11.6 billion

French multinational pharmaceutical company SANOFI logo seen at their headquater in Paris, France, March 8, 2016. REUTERS/Philippe Wojazer – D1AESRMWVNAA PARIS (Reuters) – French healthcare group Sanofi has agreed to buy U.S. haemophilia specialist Bioverativ ... More »

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Sanofi shares fall on $11.6 billion Bioverativ takeover

PARIS (Reuters) – Shares in French drugmaker Sanofi fell on Monday after the company announced a $11.6 billion takeover of U.S. haemophilia treatment specialist Bioverativ, with some traders saying the price looked expensive. Sanofi shares were down 2.3 percen... More »

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Google venture arm backs UK universal flu vaccine company

LONDON (Reuters) – A private British company developing a vaccine that would be the first in the world to fight all types of flu has raised 20 million pounds ($27 million) from investors including GV, the venture capital arm of Google parent Alphabet Inc. Vacc... More »

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U.S. ‘socially screened’ funds draw second-biggest inflows ever

FILE PHOTO: A U.S. Dollar note is seen in this June 22, 2017 illustration photo. REUTERS/Thomas White/Illustration/File Photo NEW YORK (Reuters) – U.S. investors poured $4.7 billion into so-called socially responsible mutual funds and exchange-traded funds in ... More »

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Drugmakers see a pricing blueprint in an $850,000 gene therapy

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 »

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Eastman Kodak unveils cryptocurrency, stock doubles

The Kodak logo is shown on a booth during the 2017 CES in Las Vegas, Nevada, U.S., January 6, 2017. REUTERS/Steve Marcus SAN FRANCISCO (Reuters) – Shares of Eastman Kodak Co (KODK.N) more than doubled on Tuesday after the one-time leader in photography became ... More »

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Rising tide in U.S. markets helps bonds, global stocks

NEW YORK (Reuters) – Investors sitting on U.S. stock returns need a place to put the money, and the big winners are international markets and high-rated debt issuers from corporations to governments. U.S. fund investors pulled $8.4 billion from stocks and funn... More »

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Roche to buy U.S. cancer drugmaker Ignyta for $1.7 billion

FILE PHOTO: The logo of Swiss pharmaceutical company Roche is seen outside their headquarters in Basel, Switzerland, January 30, 2014. REUTERS/Ruben Sprich/File Photo (Reuters) – Swiss drugmaker Roche (ROG.S) will buy U.S. cancer drugmaker Ignyta Inc (RXDX.O) ... More »

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FDA approves La Jolla’s low blood pressure drug

(Reuters) – La Jolla Pharmaceutical said on Thursday the U.S. Food and Drug Administration had approved its drug, Giapreza, to treat dangerously low blood pressure. The company said it plans to make Giapreza available for patients in the United States in March... More »

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U.S. lifts funding ban on studies that enhance dangerous germs

A girl wearing a mask looks out a car window as rain drops are seen in Taif June 7, 2014. REUTERS/Mohamed Alhwaity CHICAGO (Reuters) – The U.S. government on Tuesday lifted a 2014 temporary ban on funding research involving the flu and other pathogens in which... More »

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Tiny stem cell companies close in on major heart disease goals

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 »

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Aclaris’s drug to treat common skin growth gets FDA nod

(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 »

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FDA allows Alnylam to restart hemophilia treatment trials

(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 »

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Germany’s Merck in fresh bid to enter U.S. MS pill market

The logo of German pharmaceuticals company Merck is seen in front of the company’s headquarters in Darmstadt, Germany, May 16, 2016. REUTERS/Kai Pfaffenbach FRANKFURT (Reuters) – Germany’s Merck KGaA (MRCG.DE) is reviving plans to bring an oral multiple sclero... More »

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Roche study finds cancer ‘Velcro’ that halts T-cell attack

Swiss drugmaker Roche’s logo is seen at their headquarters in Basel, Switzerland January 28, 2016. REUTERS/Arnd Wiegmann ZURICH (Reuters) – Scientists at Swiss drugmaker Roche said on Friday they may have discovered why some tumors resist new immunotherapy dru... More »

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Sage shares surge as depression drug succeeds in mid-stage trial

(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 »

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Indivior drug to fight opioid addiction approved by U.S. FDA

(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 »

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Foundation’s cancer gene test gets U.S. FDA and Medicare nod

CHICAGO (Reuters) – A test from Foundation Medicine Inc that can detect cancer-causing mutations in 324 genes has won approval from the U.S. Food and Drug Administration and the Center for Medicare and Medicaid Services, the agencies said. The test, known as F... More »

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Bayer pharmaceuticals head says there’s no pipeline problem

LEVERKUSEN, Germany (Reuters) – Bayer is seeking to defend its pharmaceuticals business that will be diluted in importance by the takeover of Monsanto and faces a threat to revenues in 2024 when the blockbuster heart drug Xarelto loses its patent. The firm’s p... More »

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U.S. approves digital pill that tracks when patients take it

A digital pill with an embedded sensor to track if patients are taking their medication. REUTERS/Proteus Digital Health (Reuters) – U.S. regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication pr... More »

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J&J`s Stelara shows promise against lupus in study

Johnson & Johnson's blockbuster psoriasis drug Stelara led to a significant reduction in disease activity in patients with systemic lupus compared with a placebo in a midstage clinical trial, according to data released on Saturday. More »

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U.S. healthcare brightens tame U.S. high-grade M&A lending

CVS Health Corp’s planned US$66bn buy of Aetna Inc is poised to boost the healthcare sector’s share of US investment-grade mergers and acquisitions lending beyond its current one-third share of the US$122bn total as the sector remains a bright spot in an other... More »

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Merck Keytruda sales soar, but European application pulled

Merck & Co (MRK.N) on Friday said quarterly sales of its Keytruda cancer immunotherapy exceeded $1 billion for the first time, but it withdrew an application for European use of the drug in lung cancer, raising questions about future sales. More »

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Billionaire Insys founder charged in U.S. opioid bribe case

The billionaire founder of Insys Therapeutics Inc was arrested on Thursday on U.S. charges he participated in a scheme to bribe doctors to prescribe a fentanyl-based cancer pain drug, marking a step by authorities to fight the opioid epidemic. More »

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Regeneron-Sanofi drug succeeds mid-stage study

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 »

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FDA panel backs gene therapy for rare form of blindness

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 »

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Flexion`s knee pain drug gets FDA nod, shares hit life high

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 »

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Lilly wins Alimta patent dispute in U.S.

The U.S. Patent and Trademark Office ruled in favor of Eli Lilly and Co in a patent dispute over its cancer drug Alimta with Neptune Generics LLC and Sandoz Inc. More »

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FDA aims to speed up arrival of complex generic drugs

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 »