BioCentury | Jun 12, 2020
Regulation

Approval of Biocon, Mylan insulin product could herald cheaper insulin in U.S.

After traveling a winding path that included patent disputes and complete response letters, Semglee insulin glargine from Biocon and Mylan has at last gained FDA’s approval to treat diabetes. Biocon Ltd. (NSE:BIOCON; BSE:532523) and Mylan...
BioCentury | Mar 16, 2020
Product Development

Teva, Celltrion launch fourth U.S. Herceptin biosimilar at modest discount

Teva and Celltrion Monday launched Herzuma trastuzumab-pkrb, a biosimilar version of Genentech’s Herceptin trastuzumab, in the U.S. at a 10% discount to the original product. The launch price suggests that unlike generic drugs, the launch...
BioCentury | Mar 11, 2020
Product Development

Biocon, Mylan look ahead to U.S. launch of insulin glargine as last Lantus patent falls for Sanofi

A district court decision in favor of Biocon and Mylan sets the partners up to launch their version of insulin glargine in the U.S. midyear should the candidate get FDA approval in June. The partners...
BioCentury | Mar 10, 2020
Politics, Policy & Law

We’ve moved on from nude women parties. The progress is much bigger than that.

Sunday was International Women’s Day. I looked back at a column I wrote in 2018 wondering how much of it was still relevant. Can something as fundamental as the situation for women in our industry...
BC Extra | Jan 28, 2020
Company News

Jan. 27 Company Quick Takes: Enhertu meets in pivotal gastric cancer study; plus Biocon-Mylan, CMS, Lilly-Boehringer, Ningbo-Genentech

Japan submission on horizon for AZ, Daiichi’s ADC  Daiichi Sankyo Co. Ltd. (Tokyo:4568) plans to seek approval of Enhertu for gastric cancer starting in Japan after the anti-HER2 antibody-drug conjugate met the primary and a...
BC Extra | Jan 25, 2020
Company News

Pfizer seeking to dent market share with trio of discounted biosimilars

Pfizer is hoping that discounts of 22-24% from reference drugs’ wholesale acquisition costs (WACs) will help it gain market share for three new or soon-to-be launched biosimilars, each of which will compete with at least...
BioCentury | Jan 8, 2020
Politics, Policy & Law

Over 200 biopharma leaders endorse commitment to patients and the public

Dismayed by their industry’s abysmal reputation, leaders of small and medium-sized biotechs are taking rebuilding public trust into their own hands. Led by six CEOs, executives representing over 150 companies have signed an open letter...
BC Extra | Jan 7, 2020
Company News

Management tracks: New director for CMS’s CMMI, plus FibroGen, Turning Point, Akcea, Antengene, Biocon and more

CMS appointed Brad Smith as director of the Center for Medicare & Medicaid Innovation , through which HHS plans to implement the Trump administration’s proposed International Pricing Index model for Medicare Part B drugs. Smith, who...
BioCentury | Dec 7, 2019
Product Development

U.S. biosimilars glass--half full or half empty?

Ten years after the U.S. created a pathway for biosimilars--and four and a half years after the first FDA approval--a few manufacturers have demonstrated that they can overcome the technical, regulatory and commercial barriers to...
BC Extra | Dec 4, 2019
Company News

Management tracks: Mittal to succeed Biocon’s Chandavarkar; plus Intercept, Nektar, Agios, Accelerate, ABPI and more

CFO Siddharth Mittal will succeed Arun Chandavarkar as CEO and joint managing director of Biocon Ltd. (NSE:BIOCON; BSE:532523). Chandavarkar, who retired last month, had been with the Indian biopharma since 1990. Mittal joined in 2013...
Items per page:
1 - 10 of 381
BioCentury | Jun 12, 2020
Regulation

Approval of Biocon, Mylan insulin product could herald cheaper insulin in U.S.

After traveling a winding path that included patent disputes and complete response letters, Semglee insulin glargine from Biocon and Mylan has at last gained FDA’s approval to treat diabetes. Biocon Ltd. (NSE:BIOCON; BSE:532523) and Mylan...
BioCentury | Mar 16, 2020
Product Development

Teva, Celltrion launch fourth U.S. Herceptin biosimilar at modest discount

Teva and Celltrion Monday launched Herzuma trastuzumab-pkrb, a biosimilar version of Genentech’s Herceptin trastuzumab, in the U.S. at a 10% discount to the original product. The launch price suggests that unlike generic drugs, the launch...
BioCentury | Mar 11, 2020
Product Development

Biocon, Mylan look ahead to U.S. launch of insulin glargine as last Lantus patent falls for Sanofi

A district court decision in favor of Biocon and Mylan sets the partners up to launch their version of insulin glargine in the U.S. midyear should the candidate get FDA approval in June. The partners...
BioCentury | Mar 10, 2020
Politics, Policy & Law

We’ve moved on from nude women parties. The progress is much bigger than that.

Sunday was International Women’s Day. I looked back at a column I wrote in 2018 wondering how much of it was still relevant. Can something as fundamental as the situation for women in our industry...
BC Extra | Jan 28, 2020
Company News

Jan. 27 Company Quick Takes: Enhertu meets in pivotal gastric cancer study; plus Biocon-Mylan, CMS, Lilly-Boehringer, Ningbo-Genentech

Japan submission on horizon for AZ, Daiichi’s ADC  Daiichi Sankyo Co. Ltd. (Tokyo:4568) plans to seek approval of Enhertu for gastric cancer starting in Japan after the anti-HER2 antibody-drug conjugate met the primary and a...
BC Extra | Jan 25, 2020
Company News

Pfizer seeking to dent market share with trio of discounted biosimilars

Pfizer is hoping that discounts of 22-24% from reference drugs’ wholesale acquisition costs (WACs) will help it gain market share for three new or soon-to-be launched biosimilars, each of which will compete with at least...
BioCentury | Jan 8, 2020
Politics, Policy & Law

Over 200 biopharma leaders endorse commitment to patients and the public

Dismayed by their industry’s abysmal reputation, leaders of small and medium-sized biotechs are taking rebuilding public trust into their own hands. Led by six CEOs, executives representing over 150 companies have signed an open letter...
BC Extra | Jan 7, 2020
Company News

Management tracks: New director for CMS’s CMMI, plus FibroGen, Turning Point, Akcea, Antengene, Biocon and more

CMS appointed Brad Smith as director of the Center for Medicare & Medicaid Innovation , through which HHS plans to implement the Trump administration’s proposed International Pricing Index model for Medicare Part B drugs. Smith, who...
BioCentury | Dec 7, 2019
Product Development

U.S. biosimilars glass--half full or half empty?

Ten years after the U.S. created a pathway for biosimilars--and four and a half years after the first FDA approval--a few manufacturers have demonstrated that they can overcome the technical, regulatory and commercial barriers to...
BC Extra | Dec 4, 2019
Company News

Management tracks: Mittal to succeed Biocon’s Chandavarkar; plus Intercept, Nektar, Agios, Accelerate, ABPI and more

CFO Siddharth Mittal will succeed Arun Chandavarkar as CEO and joint managing director of Biocon Ltd. (NSE:BIOCON; BSE:532523). Chandavarkar, who retired last month, had been with the Indian biopharma since 1990. Mittal joined in 2013...
Items per page:
1 - 10 of 381