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Why Former Novartis CEO Joe Jimenez Joined A Microbiome Startup’s Board

uBiome, a San Francisco startup that sells commercial tests that use DNA sequencing to identify what microbes are in a person's stool or, for one test, in the vagina, has raised $83 million from venture capitalists to fund an entrée into drug development.




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Bioclinical, VivaLNK unveil remote patient monitoring technology

The solutions enable continuous remote monitoring of body temperature and other vitals, either at home or in care centers, for clinical trials.




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US trials of Pfizer/BioNTech coronavirus vaccine start

It is hoped that the drug may prevent COVID-19




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Pfizer and BioNTech move on COVID-19 vaccine work apace

As with other companies, US drug giant Pfizer and its German partner BioNTech are moving forward their…



  • BioNTech/BNT162/Coronavirus/Drug Trial/Focus On/Pfizer/Pharmaceutical/Research/USA/Vaccines

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Ferring in sight of finish line with first microbiome-based drug

Swiss drugmaker Ferring and its Rebiotix subsidiary have announced a world first with a microbiome-based…



  • Antibiotics and Infectious diseases/Biotechnology/Drug Trial/Ferring Pharmaceuticals/Microbiomes/RBX2660/Rebiotix/Research/Switzerland

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Bausch + Lomb licenses Stada and Xbrane’s Lucentis biosimilar

Eye health specialist Bausch + Lomb, part Bausch Health Companies, has entered into an exclusive licensing…



  • Bausch & Lomb/Bausch Health Companies/Biosimilars/Canada/Deals/Germany/Licensing/Lucentis/Ophthalmics/STADA Arzneimittel/Sweden/USA/Xbrane Biopharma AB/Xlucane

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Global pharma and biotech’s fight against COVID-19: an investment perspective

Mark Brewer, who heads up the life sciences team at UK broker and M&A advisory company, finnCap, gives…



  • Actemra/Anti-virals/Avacta/Avigan/Biotechnology/Business Financing/Chloroquine/Coronavirus/Cytiva/Expert View/Faron Pharmaceuticals/favipiravir/Focus On/Fujifilm/Gilead Sciences/Hydroxychloroquine/In Depth/Medical Devices and Diagnostics/Novacyt/Remdesivir/Roche/SNG001/Synairgen/UK

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Biogen gears up Swiss manufacturing facility for potential aducanumab rollout

Biogen has had a rocky road with its controversial Alzheimer's disease candidate aducanumab, resurrected late last year. But despite postponing the drug's FDA filing half a year, Biogen is still moving forward with plans to scale up production if aducanumab eventually passes muster.




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Best of the Best Biotech Book Recommendations

As you may know, I maintain an extensive list of book recommendations for the biotech enthusiast on a "Amazon Influencer" page. After the latest update there are well over 100 titles! I recently analyzed the data to come up with the most popular titles among my followers (perhaps the full list is a bit intimidating):​Genentech: The Birth of BiotechThe Biotech Trader HandbookThe Pharmagellan Guide to Biotech Forecasting & ValuationValuation in Life Sciences: A Practical GuideThe Antidot [...]




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Biotech Reading List

I Thought Being a Health Care Reporter Would Make Cancer Easier. I Was Wrong.Alexandra Glorioso (Politico Magazine)Meet the pigs that could solve the human organ transplant crisisKaren Weintraub (MIT Technology Review)The Director of the NIH Lays Out His Vision of the Future of Medical ScienceFrancis Collins (Time)In a rural Wisconsin village, the doctor makes house calls — and sees some of the rarest diseases on EarthMark Johnson (Milwaukee Journal Sentinel)‘I just want to live [...]



  • biotech reading list

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Ohio Edison Agrees to Repower Power Plant with Renewable Biomass Fuel

Ohio Edison Company, a subsidiary of FirstEnergy Corp., has agreed in a consent decree to repower one of its coal-fired power plants using primarily renewable biomass fuels.



  • OPA Press Releases

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Six Individuals, Three Corporations Charged in Indiana-based Biofuels Fraud Scheme

The Justice Department’s Environment and Natural Resources Division and the U.S. Attorney’s Office for the Southern District of Indiana announced today the return of two indictments against six individuals and three companies for offenses involving federal renewable fuel programs, allegedly creating losses to victims totaling more than $100 million. The 88 counts included in the three charging documents include allegations of conspiracy, wire fraud, false tax claims, false statements under the Clean Air Act, obstruction of justice, money laundering and securities fraud.



  • OPA Press Releases

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Two Men Charged in Las Vegas with Biofuels Fraud Scheme

Two men have been indicted by a federal grand jury in Las Vegas for offenses involving the federal renewable fuel program that allegedly netted them more than $37 million.



  • OPA Press Releases

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Houston Man Charged with Biofuels Fraud Scheme

A federal grand jury in Houston, Texas, today indicted Philip Joseph Rivkin, a/k/a Felipe Poitan Arriaga, for offenses involving a federal renewable fuel program that allegedly netted him more than $29 million, the Justice Department’s Environment and Natural Resources Division announced. The 68-count indictment against Rivkin, 49, of Houston and most recently, Guatemala City, Guatemala, includes allegations of wire fraud, mail fraud, Clean Air Act false statements, and money laundering



  • OPA Press Releases

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Australian Man Pleads Guilty in Las Vegas to Biofuels Fraud Scheme

Nathan Stoliar, 64, of Australia, pleaded guilty in federal court in Las Vegas today to five felonies for his role in multiple schemes, worth in excess of $41 million, to generate fraudulent biodiesel credits and to export biodiesel without providing biodiesel credits to the United States as required by law



  • OPA Press Releases

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Vir Biotechnology, Alnylam Identify VIR-2703 Candidate For Treatment Of COVID-19

Vir Biotechnology, Inc. (VIR) and Alnylam Pharmaceuticals, Inc. (ALNY) announced Monday that they have selected a development candidate (DC) for VIR-2703 (ALN-COV), an investigational RNAi therapeutic targeting the SARS-CoV-2 (COVID-19) genome.




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Sutro Biopharma Reports Updated Data From Ovarian Cancer Study

Sutro Biopharma Inc.'s (STRO) interim phase I updated clinical data for a dose-escalation study of antibody drug-conjugate STRO-002 in ovarian cancer has been encouraging.




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RedHill Biopharma Provides Update On Compassionate Use Program With Opaganib

Biopharmaceutical company RedHill Biopharma Ltd. (RDHL) on Monday provided an additional update on the compassionate use program with its investigational drug, opaganib (Yeliva, ABC294640)1, in patients with confirmed SARS-CoV-2 infection (the cause of COVID-19) in Israel.




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Biotech Stocks Facing FDA Decision In May 2020

So far this year, 16 novel drugs have received FDA approval compared to 9 which were greenlighted during the same period last year. Now, let's take a look at the biotech stocks that are awaiting a regulatory decision in May 2020.




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Antibiotics Currently in Global Clinical Development

As of December 2019, approximately 41 new antibiotics with the potential to treat serious bacterial infections were in clinical development, and four were approved since the previous update in June 2019. The success rate for clinical drug development is low; historical data show that, generally, only 1 in 5 infectious disease products that enter human testing (phase 1 clinical trials) will be...




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The Invaluable Role of Antibiotics—in a Pandemic and Beyond

The COVID-19 pandemic is providing a grim reminder of an unfortunate truism: Public health often does not receive the attention it deserves until a disaster hits.




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How COVID-19 Is Increasing Antibiotic Use

In the span of just a few short months, the ramifications and impact of COVID-19 have been vast. Virtually every aspect of public health has been affected by this pandemic, and the fight against antibiotic-resistant bacteria is no exception.




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Our 2019 Year In Review: Macro, Biotech, and Atlas

It’s that time of year again when we pause to reflect on the state of the industry – and there’s more to focus on in biopharma today than just the drug pricing debate. As I described last year, we host

The post Our 2019 Year In Review: Macro, Biotech, and Atlas appeared first on LifeSciVC.




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Wither New Biotech Startups?

Biotech is in the midst of an incredible era of innovation: new modalities and novel medicines delivering real value to patients, leading to a decade-long bull cycle. It’s been exhilarating to watch and participate in this market, and venture capital

The post Wither New Biotech Startups? appeared first on LifeSciVC.




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BioPharma M&A Drives More Efficient Resource Allocation

M&A is an omnipresent reality in the biopharma industry, from Big Pharma mega-mergers to smaller acquisitions of emerging startups. We’ve recently witnessed several large M&A transactions get closed or announced, including BMS-Celgene, Takeda-Shire, and AbbVie-Allergan; according to BMO Capital Markets

The post BioPharma M&A Drives More Efficient Resource Allocation appeared first on LifeSciVC.




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Strategic Planning In Biotech During A Pandemic Crisis

In the throes of a full COVID-19 pandemic, most business leaders’ top priority is rightfully the health and safety of their employees, families, and communities. Even though business disruptions are significant and overwhelming, the primary efforts focused on both safety

The post Strategic Planning In Biotech During A Pandemic Crisis appeared first on LifeSciVC.




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Booming VC-Backed Biopharma: Strong Market Despite Pandemic

Venture capital is a long investment cycle business, and never before has that been so clear as now in the face of the ongoing COVID pandemic. Even with the unprecedented public equity market volatility, venture investing into private biopharma companies

The post Booming VC-Backed Biopharma: Strong Market Despite Pandemic appeared first on LifeSciVC.




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Value Creation And Destruction: Dispersion of Performance In Biotech IPOs

The biotech IPO market in 2020 remains strong, despite the volatility and COVID headwinds. We’ve seen stellar pricings and good after-market performance, with ten new offerings already this year. And the queue for companies with active S1’s on file is

The post Value Creation And Destruction: Dispersion of Performance In Biotech IPOs appeared first on LifeSciVC.




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BASF Launches Breakthrough Absorption Technology as GOED Raises Bioavailability Challenge to Omega-3 Industry

BASF recently announced the launch of Accelon™ absorption accelerating technology, developed as a breakthrough solution to the bioavailability challenge of today’s omega-3 supplements.




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Chronic migraine sufferer turns pain into passion with biotech startup

A doctor, researcher and former chronic migraine sufferer, has launched her own biotech startup company named KetoSwiss selling supplements that she argues can help control migraine pain by tapping into our own biological mechanisms.



  • Markets and Trends

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Biodiversity Essential to APEC Economies

2020 APEC Science Prize Open for Nominations




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Ra makes nine Mass. biotech IPOs, over $640M raised, this year

Wednesday’s initial public offering for Cambridge-based Ra Pharmaceuticals marked the ninth biotech startup to go public this year, tying the number in 2013 but still less than either of the two years since. Ra (Nasdaq: RARX), which has 40 employees in one of the former Pfizer buildings in Alewife, ended up with the third-largest IPO size for any Massachusetts-based biotech in 2016, with a total of $92 million raised from the sale of 7 million shares for $13 each. That’s more than the $86 million…




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Biocon/Mylan launch pegfilgrastim biosimilar Fulphila in Australia

US-based drugmaker Mylan and partner India-based biologicals specialist Biocon have announced the launch of their pegfilgrastim biosimilar, Fulphila, in Australia. The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.




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Non-innovator biologicals in India: regulatory context and areas for improvement

There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal.




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Celltrion files application with EMA for adalimumab biosimilar

Celltrion has submitted an application to the European Medicines Agency (EMA) for its adalimumab biosimilar, currently known as CT-P17.




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Online education for diabetes specialists on biosimilar insulins

An online educational course has been published by Medscape in collaboration with the Association of Diabetes Care & Education Specialist.




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Mycenax sells tocilizumab biosimilar to Richter

Taiwanese biosimilars developer Mycenax announced on 28 April 2020 that it had made a deal with Hungary-based Gedeon Richter (Richter) regarding its tocilizumab biosimilar.




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How to make biological drugs more affordable

Biological drugs remain unaffordable for many in the US due to strategies used by pharmaceutical companies and negative messaging about biosimilars, explains a recent commentary by Dr Joel Lexchin, School of Health Policy and Management at York University, Canada [1].




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China publishes draft guideline for bevacizumab copy biologicals

On 7 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of bevacizumab copy biologicals. This guidance is the second specific guideline released by the CDE in April. The agency also released guidance on adalimumab on 1 April 2020 [1].




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Pegfilgrastim biosimilar Fulphila launched in Canada

US-based drugmaker Mylan and partner, India-based biologicals specialist Biocon, announced on 28 April 2020 the launch of their pegfilgrastim biosimilar, Fulphila, in Canada. This is the second biosimilar from the pair to be launched in the country.




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AskBio buys BrainVectis for early-stage gene therapies

AskBio acquires gene therapy biotech working on treatments for neurodegenerative disorders.



  • Markets & Regulations

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Sanofi insulin biosimilar close to European entrance

Sanofiâs insulin aspart biosimilar receives positive opinion from the EMAâs CHMP.



  • Markets & Regulations

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The Pharmaceutical-Biotech-Devices Industries Face a New World Post-Pandemic

There is going to be a time in the not too distant future, when the fuller picture of the healthcare impacts of COVID-19 come into sharper focus. When that happens, it is not likely to be pretty. In large part, … Continue reading




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BioMarin pens gene therapy pact with little-known Swiss biotech

BioMarin Pharmaceutical is boosting its early-stage pipeline by penning a deal with Swiss startup Dinaqor.




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Pfizer, BioNTech dose first U.S. subject with COVID-19 vaccine

Pfizer and BioNTech have begun dosing participants in a U.S. clinical trial of their COVID-19 vaccine candidates. The dose-escalation stage of the trial will enroll up to 360 subjects, initially out of sites in New York and Maryland.




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Months after closing $617M life sciences fund, Frazier Healthcare nabs biopharma vets

Venture capital firm Frazier Healthcare has grabbed Scott Byrd, Ian Mills, and Gordon McMurray as its new Entrepreneur-in-Residence consultants.




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PTC Therapeutics nabs 'phase 3 ready' biotech Censa for just $10M upfront plus stock

PTC Therapeutics is adding to its rare disease pipeline with a midstage biotech buyout with a low upfront payment tied in with stock and biobucks.




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Probiotic combination boosts amino acid absorption from plant protein: RCT

A novel combination of two Lactobacillus paracasei strains may increase absorption of key amino acids in plant proteins, according to a new placebo-controlled, randomized, double-blind, multicenter, crossover study.




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NutraCast Podcast: Michelle Ricker on biohacking

Youâve likely heard of life hacks, which are tricks or shortcuts that help you be more efficient in life. You may or may not have heard of biohacks. But chances are, youâve already tried some without even knowing it. You might even be biohacking right nowâ




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Bifido probiotic may enhance effects of exercise and boost training results: Study

Combining exercise with a bacterial strain isolated from an Olympic weightlifting gold medalist may synergistically increase endurance compared to training or the probiotic alone, suggests data from a mouse study.