Thu.Jan 19, 2023

article thumbnail

3 biotech executives on the year ahead: deals, drug pricing and the down market

Bio Pharma Dive

“What we’re experiencing now is the aftershock of the party that went on for the last three years,” said Ovid CEO Jeremy Levin in a BioPharma Dive panel that included former Sage head Jeff Jonas and biotech entrepreneur Greg Verdine

Marketing 267
article thumbnail

US FDA grants Fast Track status for Avidity’s AOC 1020 to treat FSHD

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Fast Track designation for Avidity Biosciences’ AOC 1020 to treat facioscapulohumeral muscular dystrophy (FSHD).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Editas, in next restructuring step, to sell cell therapy work to Shoreline

Bio Pharma Dive

Shoreline will acquire a preclinical NK cell therapy Editas has been developing, as well as a license to use the CRISPR biotech’s gene editing technology

article thumbnail

Sun Pharma to buy Concert Pharmaceuticals for $576m

Pharmaceutical Technology

Sun Pharmaceutical Industries has signed a definitive agreement to buy all outstanding shares of Concert Pharmaceuticals, in a deal valued at $576m. Under the deal terms, the company will buy all shares of Concert common stock through a tender offer for $8.00 per share in cash upfront payment.

article thumbnail

2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

article thumbnail

Sun Pharma to buy Concert, pick up experimental hair loss drug

Bio Pharma Dive

Sun intends to submit the drug, called deuruxolitinib, for U.S. approval in the first half of this year, following in the footsteps of similar therapies from Pfizer and partners Eli Lilly and Incyte

Drugs 138
article thumbnail

South Korea authorises Novavax Covid-19 vaccine as booster dose

Pharmaceutical Technology

The Korean Ministry of Food and Drug Safety (KMFDS) has granted expanded approval to Novavax partner SK bioscience for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use as a booster dose in adults aged 18 and above.

More Trending

article thumbnail

Aprinoia Therapeutics and Ross sign business combination agreement

Pharmaceutical Technology

Aprinoia Therapeutics and Ross Acquisition have entered a definitive agreement for a business combination. Under the agreement, both companies will form a combined entity, dubbed Aprinoia Therapeutics, with an enterprise value of up to $319.6m.

Antibody 130
article thumbnail

Amvuttra recommended by NICE for amyloidosis

Pharma Times

Therapy is among the first to receive a positive draft recommendation under streamlined pilot process

116
116
article thumbnail

Cell therapies in AML inch closer to market while facing challenges

Pharmaceutical Technology

Acute myeloid leukemia (AML) is part of a market of blood malignancies that commercial cell therapies have not managed to penetrate yet.

article thumbnail

NeoPhore gains additional financing for discovery pipeline

Pharma Times

The new funding package will be used to progress NeoPhore’s expanding pipeline of therapies

Packaging 101
article thumbnail

An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

article thumbnail

Bluebird extends cash runway to late 2024 with $113M raise through stock sale

Fierce Pharma

Bluebird extends cash runway to late 2024 with $113M raise through stock sale esagonowsky Thu, 01/19/2023 - 08:30

Sales 98
article thumbnail

CBM looks to boost viral vector manufacturing capabilities in cell line deal

BioPharma Reporter

The unprecedented rise in approvals for new cell and gene therapies, and the increasing industry need for cell lines to support the production of therapeutics, has spurred US CDMO, the Center for Breakthrough Medicines (CBM), to act Upstream Processing

article thumbnail

Fierce Pharma Asia—China's reimbursement round; Sun's alopecia bet; GenScript's CDMO raise

Fierce Pharma

Fierce Pharma Asia—China's reimbursement round; Sun's alopecia bet; GenScript's CDMO raise aliu Thu, 01/19/2023 - 15:53

97
article thumbnail

US and Switzerland sign good manufacturing practice agreement

BioPharma Reporter

An agreement between the two countries means they can use each otherâs good manufacturing practice inspections of pharmaceutical manufacturing facilities and avoid the need for duplicate inspections. Markets & Regulations

article thumbnail

Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

article thumbnail

Roche touts industry-first liver cancer win, expects more Tecentriq adjuvant data this year

Fierce Pharma

Roche touts industry-first liver cancer win, expects more Tecentriq adjuvant data this year aliu Thu, 01/19/2023 - 09:17

97
article thumbnail

Vaxxas announces CEPI partnership to advance needle-free mRNA vaccine patches

Pharma Phorum

Biotech Vaxxas has announced a partnership agreement with the 2017-established Coalition for Epidemic Preparedness Innovations (CEPI), in order to advance the development of Vaxxas’ needle-free vaccine-patch delivery technology with preclinical testing of an mRNA vaccine patch.

article thumbnail

Is the first NASH drug approval nearing? Intercept stages comeback as FDA sets decision date 

Fierce Pharma

Is the first NASH drug approval nearing? Intercept stages comeback as FDA sets decision date aliu Thu, 01/19/2023 - 11:06

Drugs 87
article thumbnail

Sun Pharma agrees deal to buy alopecia player Concert

Pharma Phorum

India’s Sun Pharmaceutical has signed an agreement to acquire US biotech Concert Pharmaceuticals and its lead drug deuroxilitinib, in phase 3 testing for alopecia areata, a leading cause of hair loss. The $11.50

article thumbnail

Alnylam, PTC Therapeutics rare disease drugs win backing from England's NICE

Fierce Pharma

Alnylam, PTC Therapeutics rare disease drugs win backing from England's NICE zbecker Thu, 01/19/2023 - 11:53

Drugs 83
article thumbnail

JP Morgan 2023 – Raj Chopra

Pharma Phorum

On the sidelines of JP Morgan 2023, pharmaphorum editor-in-chief Jonah Comstock sat down with Raj Chopra, acting CEO of Aethon Therapeutics. Aethon recently launched January 9th, with $30 million in funding as a collaboration between Apple Tree Partners and NYU Langone Health.

Protein 79
article thumbnail

Amarin, in spat with activist investor, says Sarissa has 'no plan and no new ideas'

Fierce Pharma

Amarin, in spat with activist investor, says Sarissa has 'no plan and no new ideas' kdunleavy Thu, 01/19/2023 - 10:11

82
article thumbnail

2023 predictions and challenges in the healthcare business

Pharma Phorum

With a new year comes an opportunity for professionals in the healthcare industry to evaluate goals and initiatives for 2023. In business, we’re constantly reminded that with even the best-laid plans there come unforeseen obstacles.

article thumbnail

'The Top Line': Panelists at Fierce's JPM Week event talk drug pricing policy, and Bayer's oncology head discusses cancer strategy

Fierce Pharma

The Top Line': Panelists at Fierce's JPM Week event talk drug pricing policy, and Bayer's oncology head discusses cancer strategy qanderson Thu, 01/19/2023 - 11:05

Drugs 82
article thumbnail

A glance back to Pharma Integrates, London 2022 – part ii

Pharma Phorum

Run by Life Science Integrates, Pharma Integrates was in its 11th year in 2022.

Genome 75
article thumbnail

Upperton Pharma Solutions Begins Construction of GMP Facility

Pharmaceutical Commerce

Nottingham location expected to be fully operational by the end of 2023 us

52
article thumbnail

Making Data Exchange Feel Easy – Simplifying the Data Journey from EHR to EDC

Crucial Data Soutions

Electronic health records (EHR) are a treasure trove of data. Data from EHRs can be useful in helping study teams better understand population health, which can guide more precise recruitment efforts and provide insights that lead to more effective study designs.

article thumbnail

Cryoport, Syneos Health Form New CGT Partnership

Pharmaceutical Commerce

Cold chain company’s supply chain services experience to help facilitate therapy transport us

52
article thumbnail

The Issues That Matter Most in 2023: Medical Metaverse

Eversana Intouch

Each year, we forecast several trends that will influence life-sciences marketing the most in the months to come ahead. Success in 2023 will mean addressing each of those five issues meaningfully – understanding them fully and giving them real action, not just lip service.

article thumbnail

Seagen's targeted cancer med Tukysa picks up accelerated FDA nod in colorectal cancer

Fierce Pharma

Seagen's targeted cancer med Tukysa picks up accelerated FDA nod in colorectal cancer esagonowsky Thu, 01/19/2023 - 15:39

60
article thumbnail

Digital monitoring could be a leveller in diabetes therapy

Pharma Phorum

A digital tool developed by DarioHealth has been shown to help patients with type 2 diabetes manage their blood sugar more effectively, regardless of their demographic background, in a new study.

article thumbnail

Grant of €1.2M awarded to project researching cure for chronic bone pain

Outsourcing Pharma

Netra Pharmaâs lead product was awarded â1.2 million Eurostar grant to make an antibody therapeutic to treat arthritis and metastatic bone cancer pain. Clinical Development

article thumbnail

New patent for Biofrontera drug AMELUZ

Drug Patent Watch

Annual Drug Patent Expirations for AMELUZ Ameluz is a drug marketed by Biofrontera and is included in one NDA. It is available from one supplier. There is one patent protecting… The post New patent for Biofrontera drug AMELUZ appeared first on DrugPatentWatch - Make Better Decisions. Patent Added

article thumbnail

Health Canada consulting on wide-ranging regulatory amendments for drugs and medical devices

Pharma in Brief

Health Canada has launched a consultation on proposed amendments to the Food and Drug Regulations and Medical Devices Regulations (the Regulatory Amendments ). Consultation on the Regulatory Amendments, which have been published in the Canada Gazette, Part 1 , is open until March 27, 2023.

article thumbnail

Moderna’s RSV vaccine meets primary efficacy endpoints in Phase 3 trial

BioPharma Reporter

The candidate reported efficacy of 83.7% against RSV-associated lower respiratory tract disease: with Moderna set to file for regulatory approval for the vaccine within the first half of this year. Bio Developments

Trials 52