The FDA is extending the indication of Ibrance capsules in combination with specific endocrine therapies for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in male patients. The FDA granted the approval of Ibrance to Pfizer. “Today we are expanding the indication for Ibrance to include male patients based upon data from postmarketing reports and electronic health records showing that the safety profile for men treated with Ibrance is consistent with the safety profile in women treated with Ibrance,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
Thursday, April 4, 2019
MacroGenics’ Margetuximab advantages could be ‘compelling’: H.C. Wainwright
H.C. Wainwright analyst Debjit Chattopadhyay maintained a Buy rating and $39 price target on MacroGenics after the American Association for Cancer Research, or AACR, conference. The analyst said, “Importantly, the underlying advantages [of Margetuximab] over trastuzumab could translate into compelling OS trends favoring margetuximab, in our view,” with data expected during Q1 of 2020.
https://thefly.com/landingPageNews.php?id=2888827
https://thefly.com/landingPageNews.php?id=2888827
Novartis sues Amgen over migraine treatment Aimovig
Swiss drugmaker Novartis AG sued Amgen Inc on Thursday, accusing the U.S. biotechnology company of trying to back out of agreements to jointly develop and market Aimovig for the prevention of migraines, and keep the profits for itself.
In a complaint filed in Manhattan federal court, Novartis said it has spent several hundred million dollars on Aimovig since August 2015, when it began collaborating with Amgen, which previously controlled all rights to the treatment.
It said Amgen’s April 2 notice to end the collaboration should be deemed void because it was based on an incorrect pretext that Novartis breached the agreements when an affiliate worked with another company on a possible Aimovig rival.
Novartis called Aimovig a “runaway success,” with about 210,000 patients using the drug in the United States and another 20,000 patients elsewhere.
Aimovig won U.S. and European Union regulatory approvals last year.
The lawsuit seeks to enforce the companies’ collaboration agreements, and declare Amgen’s purported termination void.
Amgen did not immediately respond to a request for comment.
Roughly 39 million Americans suffer from migraine headaches, according to the Migraine Research Foundation.
Global drug sales to treat migraines could total $8.7 billion by 2026, according to the GlobalData analytics firm.
Aimovig belongs to a new class of migraine prevention drugs and competes with Emgality from Eli Lilly and Co and Ajovy from Teva Pharmaceutical Industries Ltd.
Sage seen by sector advisor as ‘good fit’ for Biogen, Dealreporter says
Three sector advisors told Dealreporter that they believe Biogen (BIIB) could restock its development pipeline with late-stage acquisitions in the neuroscience and gene therapy areas. One advisor said that Sage Therapeutics (SAGE) “could be a good fit if Biogen wanted to make a big splash, but said that such large-scale M&A seems unlikely for the company,” Dealreporter said, according to contacts. Sage Therapeutics shares saw a brief spike coincidental with the report from Dealreporter. In late morning trading, Sage shares are up 34c, or 0.2%, to $162.13.
Takeda invites Brazilian pharmaceutical firms to bid for Latam business
Japan’s Takeda Pharmaceutical Co Ltd has invited Brazilian pharmaceutical companies and financial investors to bid for its business in Latin America, three people with knowledge of the matter said.
The investment banking unit of Bank of America Corp is managing the sale and has invited Brazilian pharmaceutical companies Ache Laboratorios Farmaceuticos SA, EMS Pharma, Biolab Farmaceutica SA and Eurofarma Laboratorios SA to bid for the local unit, the sources added, asking for anonymity in discussing private talks.
Financial investors such as private equity firm Advent International Corp have also been invited to participate, one of the sources added.
Advent and Bank of America did not immediately comment on the matter. Biolab, Ache, Eurofarma and EMS declined to comment.
The bid format is not yet defined, as some of the strategic bidders may be interested only in Brazilian operations and others may bid for the whole regional business.
Takeda expects to fetch more than $1 billion for the Latin American operations. In Brazil, Takeda owns popular over the counter drug brands.
Brazilian newspaper Valor Economico reported some of the names of the interested parties on Thursday.
FDA warns on ‘unsubstantiated’ claims about CBD curing cancer, Alzheimer’s
Federal regulators cautioned three companies to stop making their “unsubstantiated advertising claims” on all the alleged benefits of CBD products, ranging from oils to soft gels to gummies.
The joint warning letters from the Food & Drug Administration and the Federal Trade Commission urged the three companies to rethink how they presented their products online and in social media posts. The warning letters were dated March 28, but announced Tuesday.
Outgoing FDA Commissioner Scott Gottlieb said the trio asserted “unfounded, egregious claims about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval.”
According to the letters, the sites made all sorts of claims about serious conditions including Alzheimer’s and cancer. One letter was sent to Relievus, a pain management practice with patients in New Jersey and Pennsylvania. In one statement on the company’s website, which has since been removed, Relievus said “CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”
The FDA said they made egregious claims about their products’ ability to treat or cure cancer, neurodegenerative conditions, opioid abuse, autoimmune diseases and other diseases.
Ronald Saltiel, Relievus’ chief operating officer, told MarketWatch he took down the link and wanted to follow FDA rules. At the same time, he stressed the practice’s doctors and nurse practitioners were trying to help people cope with pain without using opioids. They’ve had “nothing but positive results” with CBD, Saltiel said.
“We want to be in clinical compliance,” Saltiel said. “We disagree with some of their positions.” He said he was surprised that Relievus got a letter when plenty of other places also offered CBD products. “We’re not unique, trust me, we’re not.”
Requests for comment to the other two companies — Nutra Pure and PotNetwork Holdings — were not immediately returned.
Cannabidiol, or CBD, is a non-intoxicating cannabis derivative. It’s become a booming multi-million dollar business that’s getting mixed into everything from jelly beans to coffee and pet products. The pharmacy giant CVS CVS, +0.81% made news last month when it said it would sell CBD products in about 800 stores, and gym chains including SoulCycle peddle CBD as a pain reliever.
CBD can be found in one FDA-approved drug to treat people with epilepsy, but there’s little scientific evidence to back its support for other things like insomnia, chronic pain, depression and anxiety or, indeed, cancer.
The CBD surge is happening even with the additive in a hazy legal spot.
The 2018 farm bill said hemp was no longer deemed an illegal substance. But the bill said the FDA still had the power to regulate cannabis and its derivatives. Gottlieb said any products claiming CBD therapeutic benefits needed FDA approval for their intended use before going to market.
CBD is a non-intoxicating cannabis derivative. It’s become a booming multi-million dollar business that’s getting mixed into everything from jelly beans to coffee and pet products.
Until that time, Gottlieb said it was “unlawful” to sell food with CBD into interstate commerce, or to market it as a dietary supplement.”
And then there’s the soup of state laws on CBD and marijuana use. More than 30 states have medical marijuana laws in place and roughly 10 of those have legalized full adult marijuana use.
The FDA has previously cautioned other CBD purveyors about their claims, but the three recent letters are the first since the recent farm bill, and are the first time both the FDA and FTC have teamed up to warn about how CBD products are presented to consumers.
Mary Engle, associate director of the FTC’s Advertising Practices Division, said the commission was “always concerned about advertising claims affecting consumers’ health or safety, and is particularly concerned about products purporting to treat serious diseases such as Alzheimer’s and cancer. Regardless of the type of product, marketers must have solid science to back up their claims that a product can improve people’s health. Under FTC law, CBD products are no different.”
The feds aren’t the only government officials grappling with CBD use. New York City health officials have also ordered restaurants not to sell CBD-infused products. Meanwhile, Louisiana officials also recently said that, for the time being, they’ll give citations to retailers selling CBD products. At the same time, a new Maine law will allow CBD’s inclusion in food.
The FDA will hold a May 31 public hearing for more information about CBD.
Paul Armentano, deputy director of NORML, an advocacy group pushing for consumer access to safe, affordable marijuana, noted the FDA has taken action for years on CBD-infused products.
Armentano didn’t comment on the three latest warning letters, but said his organization “has been on record calling for greater regulatory oversight of these mass-marketed products, many of which are entirely unregulated and of varying quality.”
Subscribe to:
Posts (Atom)