The U.S. Food and Drug Administration on Wednesday said a method of
testing the drug ranitidine for impurities is not suitable to detect the
presence of NDMA, a possible carcinogenic, because the testing method
may generate NDMA.
According to the agency, a testing method employing high temperatures
“generated very high levels of NDMA from ranitidine products because of
the test procedure.” That method was used by a third-party laboratory,
whose work was observed by the FDA.
The FDA said a liquid chromatography-high resolution mass
spectrometry, or LC-HRMS, method should be used to test for the presence
of NDMA. “FDA’s LC-HRMS testing method does not use elevated
temperatures and has shown the presence of much lower levels of NDMA in
ranitidine medicines than reported by the third-party laboratory.”
The agency said it is continuing tests of ranitidine products from a
number of manufacturers, and is asking ranitidine manufacturers to send
samples of their products to the agency for testing by FDA scientists.
Ranitidine is used to treat heartburn and other gastrointestinal disorders.
The FDA last month said it detected low levels of NDMA, a probable
carcinogenic, in the heartburn treatment Zantac. Ranitidine is an active
ingredient in Zantac.
Since then, a number of retailers, including Walmart, Walgreens and Kroger have removed treatments containing ranitidine from their shelves.
In a release last month, the FDA notified professionals and patients
about the voluntary recall, but said not all ranitidine medicines are
being recalled, and added it wasn’t recommending individuals stop taking
all ranitidine medicines.
https://www.marketscreener.com/news/FDA-Recommends-Against-Using-Certain-Test-on-Ranitidine-Says-it-May-Generate-NDMA-in-Sample–29327990/
Wednesday, October 2, 2019
Puma Biotechnology +13% after FDA OKs Nerlynx label addition
Puma Biotechnology (NASDAQ:PBYI) surges 13% in after-hours trading after the U.S. Food and Drug Administration approves a labeling supplement for Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer.
With the approval of the labeling supplement, the
label now includes safety information based on interim results from
Puma’s Phase II CONTROL Trial, a study evaluating antidiarrheal
prophylaxis or dose escalation in the reduction of neratinib-associated
diarrhea that has a primary endpoint of the incidence of grade 3 or
higher diarrhea.
Interim data from the trial showed that the
addition of prophylactic treatment with loperamide and budesonide
reduced the discontinuation rate due to neratinib-associated diarrhea to
11% versus a discontinuation rate of 18% with loperamide alone.’
Neratinib was approved by the FDA in July 2017 for
extended adjuvant treatment for adult patients with early stage
HER2-positive breast cancer.
https://seekingalpha.com/news/3503593-puma-biotechnology-plus-13-percent-fda-oks-nerlynx-label-additionADC Therapeutics pulls IPO
ADC Therapeutics (ADCT) has withdrawn its IPO registration statement.
The company is a clinical-stage oncology-focused biotech.
“In light of adverse market conditions, we have
determined it is in the best interests of our shareholders to withdraw
the registration statement,” says CEO Chris Martin.
“We are fortunate to have a strong balance sheet,
highly supportive investors, alternative financing options and a steady
flow of forthcoming milestones, all of which factored into our decision
to not proceed with an initial public offering in the current market
conditions,” he adds.
It had planned to offer 8.19M common shares at $23-$26/share.
https://seekingalpha.com/news/3503611-adc-therapeutics-pulls-ipoImmunovant set to land on Nasdaq via HSAC merger
Immunovant is set to land on Nasdaq through a deal
with Health Sciences Acquisitions Corporation (HSAC), a business
founded by RTW Investments to buy a biotech. HSAC will buy the Roivant
business but the resulting company will take Immunovant’s name,
management team and strategic focus.
HSAC went public earlier this year, raising $100 million with the sole intention of acquiring a North American or European biotech or medtech. Now, HSAC has named Immunovant as its target.
Immunovant will exit the deal with an investor syndicate featuring RTW Investments, BVF Partners, Adage Capital Management, Roivant and others, plus $100 million in cash. The cash projection includes the proceeds of a $35 million bridge financing involving RTW, BVF and Roivant.
The money is forecast to see Immunovant through to the second half of 2021, by when it may have a better idea of whether its anti-FcRn monoclonal antibody IMVT-1401 can compete. Argenx has a FcRn drug in phase 3 in myasthenia gravis, one of the indications targeted by Immunovant; other companies including Alexion and UCB are also in the running.
Immunovant expects to share phase 2a data on IMVT-1401 in Graves’ ophthalmopathy in the first quarter of next year, with results from a phase 2a trial in myasthenia gravis expected to follow shortly thereafter. The company looks set to advance toward those milestones as part of HSAC.
HSAC is one of three organizations with similar goals that went public over an eight-month period starting in the back half of 2018. Chardan Healthcare Acquisition Corporation, a business set up by the investment group of the same name, listed late last year with the goal of buying a biotech, medtech or digital health startup. In July, the group struck a deal to merge with BiomX.
With HSAC hooking up with Immunovant, Perceptive Advisors’ Arya Sciences Acquisition Corporation is the only one of the three not to execute a transaction so far. Arya raised $125 million in an IPO a little more than one year ago and has around one year more to seal a deal.
https://www.fiercebiotech.com/biotech/immunovant-set-land-nasdaq-via-hsac-merger
HSAC went public earlier this year, raising $100 million with the sole intention of acquiring a North American or European biotech or medtech. Now, HSAC has named Immunovant as its target.
Immunovant will exit the deal with an investor syndicate featuring RTW Investments, BVF Partners, Adage Capital Management, Roivant and others, plus $100 million in cash. The cash projection includes the proceeds of a $35 million bridge financing involving RTW, BVF and Roivant.
The money is forecast to see Immunovant through to the second half of 2021, by when it may have a better idea of whether its anti-FcRn monoclonal antibody IMVT-1401 can compete. Argenx has a FcRn drug in phase 3 in myasthenia gravis, one of the indications targeted by Immunovant; other companies including Alexion and UCB are also in the running.
Immunovant expects to share phase 2a data on IMVT-1401 in Graves’ ophthalmopathy in the first quarter of next year, with results from a phase 2a trial in myasthenia gravis expected to follow shortly thereafter. The company looks set to advance toward those milestones as part of HSAC.
HSAC is one of three organizations with similar goals that went public over an eight-month period starting in the back half of 2018. Chardan Healthcare Acquisition Corporation, a business set up by the investment group of the same name, listed late last year with the goal of buying a biotech, medtech or digital health startup. In July, the group struck a deal to merge with BiomX.
With HSAC hooking up with Immunovant, Perceptive Advisors’ Arya Sciences Acquisition Corporation is the only one of the three not to execute a transaction so far. Arya raised $125 million in an IPO a little more than one year ago and has around one year more to seal a deal.
https://www.fiercebiotech.com/biotech/immunovant-set-land-nasdaq-via-hsac-merger
Organovo pops on merger offer from firm led by co-founder
Organovo (ONVO +5.6%) is higher after receiving a formal merger proposal
from Viscient Biosciences, whose CEO, Keith Murphy, was a co-founder of
Organovo and the company’s CEO and Chairman during 2007-17.
“Having already established the paradigm for drug
discovery in 3D tissue in liver, Viscient now has the potential to
efficiently use the other tissues in Organovo’s portfolio to develop
drugs for additional high-value indications,” Murphy says, adding a
combined company “could be valued in the hundreds of millions over the
next couple of years.”
Viscient envisions the combined company could be
as much as 43% owned by ONVO’s existing shareholders and the rest owned
by Viscient shareholders.
https://seekingalpha.com/news/3503488-organovo-pops-merger-offer-firm-led-former-founderApolloMed adds 145K members with new management services agreement
Health management firm Apollo Medical Holdings (NASDAQ:AMEH) has entered into a new management services agreement that will add about 145,000 new members.
The deal with an independent practice association is effective Jan. 1.
The IPA group serves members in three main markets
in Southern California: South Los Angeles, San Fernando Valley, and
Antelope Valley.
That “significantly” bolsters member under
management, says Chairman/Co-CEO Kenneth Sim, adding that “Consistent
with our strategic plan, this agreement also brings the opportunity to
further scale our business model and realize additional efficiencies.”
https://seekingalpha.com/news/3503515-apollomed-adds-145k-members-new-msaEyePoint insert for uveitis gets permanent J-code
EyePoint Pharmaceuticals (NASDAQ:EYPT) jumps 4.8% in
after-hours trading after announcing that a permanent and specific
J-code for Yutiq (fluocinolone acetonide intravitreal implant) 0.18 mg
three-year micro-insert for chronic, non-infectious uveitis affecting
the posterior segment of the eye is now in effect.
The code, J7314, was issued by the CMS one quarter earlier than under prior CMS policy.
https://seekingalpha.com/news/3503572-eyepoint-insert-uveitis-gets-permanent-j-code
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