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The House Committee on Oversight and Reform announced plans to investigate the approval and pricing of the drug. Biogen, on its part, has defended its pricing.
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Although the COVID-19 pandemic is waning in the U.S., it’s not completely over and there are some concerns, particularly with the delta variant, which originated in India. Here’s a look.
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Government of Canada helping expand access to safer supply across Canada
6/28/2021
The overdose crisis continues to affect communities and families across Canada. Tragically, we have seen substantial increases in overdose deaths and related harms during the COVID-19 pandemic.
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Statement from the Chief Public Health Officer of Canada on June 28, 2021
6/28/2021
The latest epidemiology and modelling update, shows that we are continuing to make significant progress in bringing COVID-19 disease activity down and raising vaccination coverage up.
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Statement from the Chief Public Health Officer of Canada on June 27, 2021
6/27/2021
The COVID-19 pandemic continues to create stress and anxiety for many Canadians, particularly those who do not have ready access to their regular support networks.
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FDA Accepts Braeburn's New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
6/26/2021
Braeburn announces that the New Drug Application for BRIXADI extended-release weekly and monthly injection for subcutaneous use for moderate to severe opioid use disorder was accepted by the U.S. Food and Drug Administration.
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Statement from the Chief Public Health Officer of Canada on June 26, 2021
6/26/2021
The COVID-19 pandemic continues to create stress and anxiety for many Canadians, particularly those who do not have ready access to their regular support networks.
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New data continues to emerge that seems to add to the possibility of COVID-19 originating from a lab leak at China’s Wuhan Institute of Virology.
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Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo (nivolumab) as Adjuvant Treatment for Esophageal or Gastroesophageal Junction Cancer Patients with Residual Pathologic Disease Following Chemoradiotherapy
6/25/2021
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Opdivo for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy.
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Sanofi: Libtayo® (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ≥50% PD-L1 expression
6/25/2021
The European Commission has approved Sanofi and Regeneron’s PD-1 inhibitor Libtayo® for the first-line treatment of adults with non-small cell lung cancer whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations.
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Coronavirus (COVID-19) Update: FDA Authorizes Drug for Treatment of COVID-19
6/25/2021
The U.S. Food and Drug Administration issued an emergency use authorization for the drug Actemra for the treatment of hospitalized adults and pediatric patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
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Santen Receives FDA Approval for Verkazia™ (Cyclosporine Ophthalmic Emulsion) 0.1% for the Treatment of Vernal Keratoconjunctivitis in Children and Adults
6/24/2021
Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd., a global company focused exclusively on eye care, announced that the U.S. Food and Drug Administration has approved Verkazia™ 0.1% eye drops for the treatment of vernal keratoconjunctivitis in children and adults.
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Statement from the Chief Public Health Officer of Canada on June 24, 2021
6/24/2021
As COVID-19 activity continues in Canada, we are tracking a range of epidemiological indicators to monitor where the disease is most active, where it is spreading and how it is impacting the health of Canadians and public health, laboratory and healthcare capacity.
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Crisis has a way of opening doors of opportunity for fraud around the globe. The COVID-19 pandemic has brought not only a fresh slew of financial schemes, but pharmaceutical fraud as well.
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Statement from the Chief Public Health Officer of Canada on June 23, 2021
6/23/2021
As COVID-19 activity continues in Canada, we are tracking a range of epidemiological indicators to monitor where the disease is most active, where it is spreading and how it is impacting the health of Canadians and public health, laboratory and healthcare capacity.
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Public Health Vaccines Awarded First Options Under Advanced Development Contract From BARDA to Continue Development of Vaccine Against Marburg Virus
6/23/2021
Public Health Vaccines, LLC, a biotechnology company out of Cambridge, MA, has been awarded the first two options under its Biomedical Advanced Research and Development Authority contract for the advanced development of its vaccine candidate designed to prevent Marburg virus infections.
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European Commission Purchases Additional 150 Million Doses of Moderna’s COVID-19 Vaccine for Delivery in 2022
6/22/2021
Moderna, Inc., a biotechnology company pioneering messenger RNA therapeutics and vaccines, announced that the European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine, including the ability to purchase other COVID-19 vaccine candidates from Moderna’s pipeline.
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Singapore agrees to zoning arrangement to allow for safe trade from Canada in the event of an African swine fever outbreak
6/22/2021
The Honourable Marie-Claude Bibeau, Minister of Agriculture and Agri-Food announced that the Canadian Food Inspection Agency and the Singapore Food Agency have agreed to an African swine fever zoning arrangement to allow for the safe trade of swine products from disease-free zones in Canada in the event of an ASF outbreak.
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Fennec Pharmaceuticals Announces FDA Acceptance of New Drug Application Resubmission for PEDMARK™
6/22/2021
Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, announced that the U.S. Food and Drug Administration has accepted for filing the resubmission of its New Drug Application for PEDMARK™ for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors.
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This program limits the prices drug manufacturers can charge for therapies sold to specific healthcare facilities, including public hospitals and community health centers.