Sat.Dec 17, 2022 - Fri.Dec 23, 2022

article thumbnail

Curavit’s crystal ball – how will 2023 drive meaningful changes in clinical research

Pharma Phorum

The life sciences industry is flexing towards innovation in new areas, faster than ever before, and increasing patient care in astonishing ways. Decentralised oncology trials, for example, have shown actual predictive outcome value.

article thumbnail

Ferring wins FDA approval for bladder cancer gene therapy

Bio Pharma Dive

The OK caps a long development journey for the treatment, which was previously turned back by the agency. Ferring doesn’t expect it to be available until the second half of next year, however

Insiders

Sign Up for our Newsletter

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

article thumbnail

2022 in review: Regulation starts to catch up with AI in pharma

Pharmaceutical Technology

Artificial intelligence (AI) continued to stay in the news with several high-profile deals this year, as the pharmaceutical industry readily took to adopting AI models to improve drug discovery.

article thumbnail

Doctoring the Law: Congress May Let FDA Regulate the Practice of Medicine

The FDA Law Blog

By Jeffrey N. Gibbs & Sara W. Koblitz — Back in June, when Congress was negotiating the User Fee Acts, FDA asked Congress to add in some provisions reversing several lawsuits that it had just lost.

Doctors 93
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

Boehringer Ingelheim announces appointments to Board of Managing Directors

The Pharma Data

Boehringer Ingelheim announces appointments to Board of Managing Directors. Boehringer Ingelheim today announces that the Shareholders have appointed Paola Casarosa and Shashank Deshpande to the Board of Managing Directors.

article thumbnail

Europe broadens Lynparza use as FDA ups scrutiny of PARP drugs

Bio Pharma Dive

Lynparza’s authorization in first-line prostate cancer comes days after U.S. regulators delayed a decision on the same indication, a potential sign of the FDA’s concerns around PARP blockers

More Trending

article thumbnail

UK digital health project aims to tackle dysfunctional breathing

Pharma Phorum

A collaboration between academic centres in the UK has won government funding for a digital approach to dysfunctional breathing or dyspnoea, a symptom that affects around 10% of the population.

Engineer 114
article thumbnail

Astellas, Seagen and Merck Announce FDA Acceptance of sBLA for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

The Pharma Data

Astellas, Seagen and Merck Announce FDA Acceptance of sBLA for PADCEV ® (enfortumab vedotin-ejfv) with KEYTRUDA ® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer. Astellas Pharma Inc.

article thumbnail

Government spending bill would tighten FDA oversight of accelerated drug approvals

Bio Pharma Dive

The proposed bill would strengthen rules around confirmatory testing, help speed product withdrawals and set up a panel of agency officials to better coordinate policy

article thumbnail

Moderna and UK government sign deal to establish mRNA facility

Pharmaceutical Technology

Moderna and the UK government have entered a ten-year strategic collaboration to build a messenger ribonucleic acid (mRNA) research, development and manufacturing facility in the country. The latest development comes after the parties announced an agreement in principle in June this year.

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

Pfizer, Sanofi settle first California Zantac case slated for trial: report

Fierce Pharma

Pfizer, Sanofi settle first California Zantac case slated for trial: report. zbecker. Thu, 12/22/2022 - 12:38

Trials 110
article thumbnail

Kite to Acquire Tmunity Therapeutics to Pursue Next Generation CAR T-Cell Therapy Advancements in Cancer

The Pharma Data

Kite to Acquire Tmunity Therapeutics to Pursue Next Generation CAR T-Cell Therapy Advancements in Cancer.

article thumbnail

Merck builds out cancer drug pipeline with Kelun-Biotech deal

Bio Pharma Dive

The pharma will pay the Chinese drugmaker $175 million for access to seven preclinical antibody-drug conjugates, deepening ties established this year

Antibody 245
article thumbnail

EMA CHMP recommends Moderna’s Covid-19 booster for children

Pharmaceutical Technology

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 mRNA-1273.214) booster for usage in children aged six to 11 years.

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

AlzeCure’s promising Alzheimer’s abstract accepted

Pharma Times

ACD856 has also been shown across preclinical studies to improve cognition and memory

108
108
article thumbnail

Sanofi and Innate Pharma expand collaboration for natural killer cell therapeutics in oncology

The Pharma Data

Sanofi and Innate Pharma expand collaboration for natural killer cell therapeutics in oncology.

article thumbnail

Pfizer advances diabetes, obesity drug hopeful into mid-stage testing

Bio Pharma Dive

The pharma dosed the first patient in a Phase 2 study testing a treatment it hopes could compete with closely-watched weight-loss drugs from Lilly, Novo Nordisk and Amgen

Drugs 246
article thumbnail

Fentanyl: a horrifyingly disruptive drug

Pharmaceutical Technology

Fentanyl is a powerful opioid (a narcotic analgesic that is at least partly synthetic) that is being trafficked in increasing quantities from Mexico to the US by cartels.

Drugs 219
article thumbnail

Newly formed gene therapy company has genetic Parkinson’s disease in its sights

BioPharma Reporter

Replay, the genome writing company reprogramming biology by writing and delivering big DNA, has launched its third product company, Kaleibe, a HSV gene therapy company targeting genetic brain disorders. Bio Developments

DNA 106
article thumbnail

Mainz recruits first patient into biomarker research

Pharma Times

ColoAlert research could identify advanced adenomas among colorectal cancer patients

Research 104
article thumbnail

FDA lifts hold on Bluebird’s sickle cell gene therapy

Bio Pharma Dive

Removal of the partial study suspension, which the agency imposed last December after a case of persistent anemia, helps clear the way for Bluebird to submit an approval application early next year

article thumbnail

Sanofi and Innate Pharma extend cancer therapeutics partnership

Pharmaceutical Technology

Sanofi has extended the partnership with Innate Pharma for natural killer (NK) cell therapeutics in oncology. With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate.

Licensing 219
article thumbnail

Atara makes history with world-first nod for allogeneic T-cell therapy Ebvallo

Fierce Pharma

Atara makes history with world-first nod for allogeneic T-cell therapy Ebvallo. fkansteiner. Mon, 12/19/2022 - 14:06

103
103
article thumbnail

Gilead reveals positive results for domvanalimab

Pharma Times

Study uses carious drug combinations to increase survival among lung cancer patients

Drugs 100
article thumbnail

Madrigal shares triple on positive NASH study results

Bio Pharma Dive

The company said its experimental drug helped patients with the fatty liver disease while also improving fibrosis. One analyst called the readout a “major win” for Madrigal and the NASH field

Drugs 230
article thumbnail

What a mild recession could mean for small biotechs in 2023

Pharmaceutical Technology

Last week, the US Federal Reserve raised interest rates for the seventh time this year in a continuing bid to stave off worries of a recession. The International Monetary Fund predicts that real gross domestic product (GDP) growth in the US will fall from 1.6%

article thumbnail

UK, Moderna formalise 10-year vaccines alliance

Pharma Phorum

Construction will start early next year of a new manufacturing centre in the UK with the capacity to produce 250 million vaccine doses per year, the centrepiece of a 10-year alliance between the government and US biotech Moderna.

article thumbnail

Multi-million-pound funding for genomics research

Pharma Times

Vital financing will help boost diagnosis, treatment and prospects of patient groups

Genome 98
article thumbnail

Roche takes over development of Biogen-partnered lymphoma drug

Bio Pharma Dive

Glofitimab, part of a long-standing collaboration between the two companies that’s resulted in Rituxan and Ocrevus, will be the responsibility of Roche, which will pay out royalties

article thumbnail

Pfizer secures rights for RSV therapeutic candidate sisunatovir in China

Pharmaceutical Technology

Biotechnology firm LianBio has announced that Pfizer opted in to secure the right to develop and commercialise the respiratory syncytial virus (RSV) therapeutic candidate, sisunatovir, in Mainland China, Hong Kong, Macau, and Singapore.

Licensing 151
article thumbnail

US FDA green lights first gene therapy for bladder cancer

BioPharma Reporter

The US Food and Drug Administration (FDA) has approved the first gene therapy for patients with high-risk form of bladder cancer. Markets & Regulations

article thumbnail

EQRx receives MHRA marketing approval for sugemalimab

Pharma Times

Therapy treats patients with metastatic non-small cell lung cancer and has completed successful phase 3 trial

Trials 99
article thumbnail

Doubts around cancer drug target persist after Gilead, Arcus study results offer ‘mixed picture’

Bio Pharma Dive

While long anticipated trial data were technically positive, analysts questioned whether drugs aimed at ‘TIGIT’ will prove a meaningful treatment addition

Trials 220
article thumbnail

FDA grants approval for Gilead’s multi-drug resistant HIV-1 treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Sunlenca (lenacapavir) plus other antiretroviral(s) (ARV) to treat human immunodeficiency virus type 1 (HIV-1) infection.