Bio Roundup: Cerevel’s Shell, Thrive’s Rise, Drug Price Drama & More

July 31, 2020, 7:20 am

≫ Next: Bio Roundup: A Telehealth Combo, FDA’s BCMA OK, Biogen’s Bet & More

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The biotech IPO market is buzzing but Cerevel Therapeutics is showing that there’s more than one path to the public markets. This week the neuroscience drug developer reached a deal to merge with publicly traded Arya Sciences Acquisition Corp II.

If you’ve never heard of Arya (NASDAQ: ARYBU), it’s a shell company that Perceptive Advisors formed specifically to serve as a vehicle to take a private company public. Cerevel is young, but it’s pretty far along. Bain Capital and Pfizer (NYSE: PFE) launched it in 2018 with neuroscience compounds from the pharma giant’s labs. Now Arya and a... Read more »

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Bio Roundup: A Telehealth Combo, FDA’s BCMA OK, Biogen’s Bet & More

August 7, 2020, 6:44 am

≫ Next: Bio Roundup: Seres Soars, MesoBlast Vote, Duchenne Decision & More

≪ Previous: Bio Roundup: Cerevel’s Shell, Thrive’s Rise, Drug Price Drama & More

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The novel coronavirus has driven the pharmaceutical industry to upend its research priorities. Big Pharma companies are focusing on vaccine development and a slew of biotechs are testing compounds, previously intended for a wide range of indications, as potential COVID-19 treatments.

This week saw another major development brought on by industry efforts to adjust to the new realities engendered by the pandemic, with the signing of an $18.5 billion merger in the digital health sector. How the tie-up, between telemedicine company Teladoc Health and remote monitoring firm Livongo Health, was finalized was another sign of the times: late-night Zoom sessions and a... Read more »

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Bio Roundup: Seres Soars, MesoBlast Vote, Duchenne Decision & More

August 14, 2020, 6:50 am

≫ Next: Final Agenda Released for the Xcelerate Keynote Series at Biotech Week Boston

≪ Previous: Bio Roundup: A Telehealth Combo, FDA’s BCMA OK, Biogen’s Bet & More

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The road of drug development is rife with detours and disappointments but Seres Therapeutics showed this week that course corrections can work. Four years after its microbiome therapy failed in a mid-stage study, the company reported early positive data from a pivotal test of its treatment for a type of gut infection.

The results are vindication for Cambridge, MA-based Seres (NASDAQ: MCRB). They’re also validation for the emerging microbiome medicines field, which has added many companies since Seres’s high-profile setback but has yet to yield an FDA-approved product. Could the Seres capsule of bacterial spores become the first? Investors... Read more »

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Final Agenda Released for the Xcelerate Keynote Series at Biotech Week Boston

August 20, 2020, 11:25 am

≫ Next: Bio Roundup: J&J Buyout, BioMarin Rebuffed, Poseida on Hold & More

≪ Previous: Bio Roundup: Seres Soars, MesoBlast Vote, Duchenne Decision & More

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Presented by Xconomy, the 100% digital Xcelerate Keynote Series at Biotech Week Boston on Monday, Sept. 21 places a spotlight on life science leaders who are breaking new ground with methods and solutions in R&D, planning, and production that are improving patient outcomes. As the industry navigates uncertainty, the keynote speakers will help drive your business forward by sharing insights on how their sectors are adapting to challenges, combating disruptive forces, and preparing for what the future may hold.

The expert speaker lineup includes top innovators from Alnylam, Takeda, Amgen, UCB, the FDA & BIO.

Register now to lock in the... Read more »

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Bio Roundup: J&J Buyout, BioMarin Rebuffed, Poseida on Hold & More

August 21, 2020, 6:39 am

≫ Next: FDA Adds Plasma as 2nd COVID-19 Treatment Under Emergency Guidelines

≪ Previous: Final Agenda Released for the Xcelerate Keynote Series at Biotech Week Boston

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While business is historically slow in August, this month seems to be bucking the trend, just like so many other unexpected developments in 2020. Perhaps life sciences executives have been less distracted by summer excursions this year in a world in which the COVID-19 pandemic has significantly curtailed travel.

This week two pharmaceutical companies announced major acquisition agreements collectively valued at more than $10 billion, and a trio of biotechs—one with preclinical programs, another with Phase 1 trials underway, and a third with its first drug commercialized less than a year ago—raised a combined $421 million from public investors. It was a... Read more »

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FDA Adds Plasma as 2nd COVID-19 Treatment Under Emergency Guidelines

August 24, 2020, 4:12 pm

≫ Next: Biotech Roundup: FDA Culpa, Tricida Trips, Freenome’s Funding & More

≪ Previous: Bio Roundup: J&J Buyout, BioMarin Rebuffed, Poseida on Hold & More

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The FDA has authorized the use of plasma from people who have recovered from infection by the novel coronavirus as a treatment for hospitalized COVID-19 patients, a move widely perceived as influenced by political pressure given the lack of clear evidence of clinical benefit.

Treating patients with plasma—the water, salts, and proteins that make up the liquid part of blood in which blood cells and platelets are suspended—from those who have recovered from the infection is an approach that has been previously used to treat cases of other viral illnesses, including Ebola. The idea is that the antibodies generated by people... Read more »

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Biotech Roundup: FDA Culpa, Tricida Trips, Freenome’s Funding & More

August 28, 2020, 8:09 am

≫ Next: Early Bird Sale for Xcelerate at Biotech Week Boston Ends This Friday

≪ Previous: FDA Adds Plasma as 2nd COVID-19 Treatment Under Emergency Guidelines

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Among the casualties of the COVID-19 pandemic: the credibility of government agencies entrusted with protecting public health.

The FDA this week granted emergency use authorization for convalescent plasma as a treatment for infection by the novel coronavirus. FDA Commissioner Stephen Hahn and Department of Health and Human Services Secretary Alez Azar both misrepresented the magnitude of benefit shown in the clinical data used to justify the decision. Public health officials have said more rigorous testing is needed to understand just how useful the treatment could be.

Hahn tried to walk back some of his comments but the FDA wasn’t the... Read more »

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Early Bird Sale for Xcelerate at Biotech Week Boston Ends This Friday

August 31, 2020, 2:13 pm

≫ Next: Bio Roundup: Pharma M&A, AbbVie’s Cancer Bet, Biofourmis Bucks & More

≪ Previous: Biotech Roundup: FDA Culpa, Tricida Trips, Freenome’s Funding & More

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Don’t miss out on savings for this year’s online Xcelerate Keynote Series at Biotech Week Boston – our early bird sale ends this Friday!

Speakers include:

• Jeff Baker – Deputy Director, Office of Biotechnology Products, FDA
• Michelle McMurry-Heath – President & CEO, BIO
• John Maraganore – CEO, Alnylam Pharmaceuticals
• Yvonne Greenstreet – Chief Operating Officer, Alnylam Pharmaceuticals
• Andrew Plump – President, Research & Development, Takeda
• Dhavalkumar Patel – Executive Vice President & Chief Scientific Officer, UCB
• Dave Reese – Executive Vice President, Research and Development, Amgen

Register today.

In addition to Xcelerate’s four keynote sessions, your ticket also includes admission to the BioProcess International Conference virtual exhibit... Read more »

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Bio Roundup: Pharma M&A, AbbVie’s Cancer Bet, Biofourmis Bucks & More

September 4, 2020, 7:44 am

≫ Next: FDA Approves Blueprint Cancer Drug Targeting RET Genetic Signatures

≪ Previous: Early Bird Sale for Xcelerate at Biotech Week Boston Ends This Friday

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Labor Day is just around the corner and many people are looking forward to a last chance to celebrate the waning days of summer. But ahead of the holiday weekend, biopharmaceutical companies were hard at work closing deals.

Food conglomerate Nestlé is delving deeper into pharmaceuticals with its $2.6 billion deal to acquire Aimmune Therapeutics, developer of immunotherapies for food allergies. Earlier this year, Brisbane, CA-based Aimmune’s peanut allergy treatment, Palforzia, became the first FDA-approved food allergy immunotherapy. The deal activity extended to cancer immunotherapy as Gilead Sciences and AbbVie each struck up alliances to shore up their respective drug... Read more »

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FDA Approves Blueprint Cancer Drug Targeting RET Genetic Signatures

September 5, 2020, 8:15 am

≫ Next: Xconomy Awards On-Demand ‘Meet the Finalists’ Webcast Series Launches This Week

≪ Previous: Bio Roundup: Pharma M&A, AbbVie’s Cancer Bet, Biofourmis Bucks & More

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A Blueprint Medicines drug designed to address cancer that carries a certain genetic signature now has FDA approval, the latest targeted therapy to pass the regulatory bar this year.

The late Friday decision for pralsetinib (Gavreto) covers non-small cell lung cancer (NSCLC). The drug was designed to address cancers characterized by fusions or mutations of the RET gene, which produces a protein involved in cell signaling. Genetic abnormalities to the gene drive many types of cancer, including NSCLC. To be eligible for treatment, the RET alterations must first be detected by a genetic test. The drug from Cambridge, MA-based Blueprint... Read more »

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Xconomy Awards On-Demand ‘Meet the Finalists’ Webcast Series Launches This Week

September 8, 2020, 7:28 am

≫ Next: Bio Roundup: COVID-19 Pact, Gavreto Approval, Generative Biology & More

≪ Previous: FDA Approves Blueprint Cancer Drug Targeting RET Genetic Signatures

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The 2020 National Xconomy Awards complimentary two-week, 11-part, on-demand Meet the Finalists daily webcast series starts this Tuesday, Sept. 8 at 11 a.m. ET. Registration is complimentary and includes access to a networking app with already more than 400 life science contacts.

The daily series leads up to the Thursday, Sept. 24 free online National Xconomy Awards ceremony – celebrating the best in biotech.

The 11-part Meet the Finalists webcast series provides an opportunity to get to know each of the 44 individuals and companies and better understand why they have earned the right to be named a finalist.

The event series’ custom... Read more »

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Bio Roundup: COVID-19 Pact, Gavreto Approval, Generative Biology & More

September 11, 2020, 7:44 am

≫ Next: Moderna CMO Talks COVID-19 Vaccine at Xcelerate Next Week

≪ Previous: Xconomy Awards On-Demand ‘Meet the Finalists’ Webcast Series Launches This Week

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COVID-19 research efforts are often characterized as a race between companies, a description that reflects the urgency to develop a vaccine for the novel coronavirus. The description is not quite right. A race has one winner and public health officials have said we’ll need multiple vaccines to address the global need.

Vaccine developers have progressed to pivotal testing with unprecedented speed, compressing the years-long clinical testing process into months. Still, politicians have pressed companies to move even faster. This week, vaccine developers took a stand to insist that science and safety would not be sacrificed for speed. Nine companies signed a... Read more »

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Moderna CMO Talks COVID-19 Vaccine at Xcelerate Next Week

September 16, 2020, 5:50 am

≫ Next: Bio Roundup: SeaGen Scores, Dyne’s Debut, Microbiome Moves & More

≪ Previous: Bio Roundup: COVID-19 Pact, Gavreto Approval, Generative Biology & More

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The Xcelerate Keynote Series has added Moderna CMO Tal Zaks to the expert lineup of speakers set to present next Monday, Sept. 21.

As you likely know, Moderna is one of the front-runners in the COVID-19 vaccine race, and we look forward to adding his insight to a packed agenda focused on innovative solutions during this time of uncertainty. The half-day online event also includes senior leaders from Amgen, BIO, Eli Lilly, Takeda, Alnylam, and UCB, featuring discussions on regulatory guidance, pipeline management, clinical trial recruitment, incorporating diversity, safety and efficacy, and more.

Presented by Xconomy, the online event on Monday,... Read more »

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Bio Roundup: SeaGen Scores, Dyne’s Debut, Microbiome Moves & More

September 18, 2020, 8:34 am

≫ Next: Athira CEO Kawas: Alzheimer’s Drug Aims for “Recovery of Brain Function”

≪ Previous: Moderna CMO Talks COVID-19 Vaccine at Xcelerate Next Week

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Gilead Sciences CEO Daniel O’Day has spoken openly about acquisitions as a way to build up the company’s drug pipeline. This week, it made its biggest buy yet.

The $21 billion Immunomedics acquisition brings to Gilead a cancer drug that many analysts project will become a blockbuster seller. Some of those analysts think Gilead might have overpaid but the company says there were competing offers. The drug, sacitizumab govitecan (Trodelvy), is what’s called an antibody drug conjugate (ADC). This drug class has seen a lift in recent years. Four years ago, there were just three FDA-approved ADCs. The FDA has approved... Read more »

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Athira CEO Kawas: Alzheimer’s Drug Aims for “Recovery of Brain Function”

September 23, 2020, 4:57 am

≫ Next: Tau-Targeting Alzheimer’s Drug from AC Immune, Roche Fails in Phase 2

≪ Previous: Bio Roundup: SeaGen Scores, Dyne’s Debut, Microbiome Moves & More

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The key to Athira Pharma’s approach to Alzheimer’s disease is already inside each of us: a repair mechanism that can regenerate damaged neurons. What’s needed to begin the process is a pharmacological kickstart.

Athira (NASDAQ: ATHA) is developing a drug intended to turn on the repair pathway. The company’s experimental therapy is a small molecule that crosses the protective blood-brain barrier to reach its target. Leen Kawas, the founder and CEO of Seattle-based Athira, says that whereas previous drug research efforts aimed to slow the disease’s progression, Athira’s tack offers the potential to reverse the effects of Alzheimer’s.

“We hope... Read more »

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Tau-Targeting Alzheimer’s Drug from AC Immune, Roche Fails in Phase 2

September 23, 2020, 8:13 am

≫ Next: Bio Roundup: Grail Acquisition, Libra’s Launch, Tau Trial Results & More

≪ Previous: Athira CEO Kawas: Alzheimer’s Drug Aims for “Recovery of Brain Function”

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An Alzheimer’s disease drug from partners AC Immune and Roche has failed a mid-stage clinical trial, adding another compound to the list of experimental therapies that have fallen short of demonstrating that they can treat the neurodegenerative disorder.

The drug, semorinemab, was tested in patients with early Alzheimer’s disease. It did not achieve the Phase 2 study’s main goal of beating a placebo in slowing decline according to a dementia scale, AC Immune (NASDAQ: ACIU) reported Wednesday. The company added that the drug also failed to beat a placebo in secondary goals of showing improvement in cognitive symptoms and the... Read more »

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Bio Roundup: Grail Acquisition, Libra’s Launch, Tau Trial Results & More

September 25, 2020, 7:41 am

≫ Next: Bio Roundup: MESO’s Miss, Pfizer’s Cancer Bet, Vaccine Promise & More

≪ Previous: Tau-Targeting Alzheimer’s Drug from AC Immune, Roche Fails in Phase 2

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In biotech, you can go home again. Four years ago, Illumina spun out cancer diagnostics startup Grail. This week, the gene sequencing giant announced it is acquiring Grail in an $8 billion cash and stock deal.

Grail set out with the goal of developing a diagnostic test that detects cancer from the genetic snippets tumors shed into the blood. The idea is to diagnose cancer well before symptoms show, giving clinicians a better chance to treat the disease. Grail has tested its technology in tens of thousands of patients and is now preparing to launch its first product next year.... Read more »

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Bio Roundup: MESO’s Miss, Pfizer’s Cancer Bet, Vaccine Promise & More

October 2, 2020, 7:19 am

≫ Next: BIO Launches ‘Biotech Votes’ Campaign to Encourage Registration and Informed Voting

≪ Previous: Bio Roundup: Grail Acquisition, Libra’s Launch, Tau Trial Results & More

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Amid the bombast of Tuesday’s presidential debate, viewers caught some discussion about the response to the coronavirus pandemic and efforts to develop a COVID-19 vaccine. In the crosstalk, the president made an unsupported claim that we are weeks away from having vaccines.

It’s true that some pharmaceutical companies are already manufacturing their COVID-19 vaccine candidates for broader use. This production ensures that vaccine product is ready for distribution upon receiving a regulatory decision. But companies undertake this manufacturing “at-risk” because they don’t yet know how well their vaccines will work or if they’ll be approved. The industry is pushing back, even... Read more »

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BIO Launches ‘Biotech Votes’ Campaign to Encourage Registration and Informed Voting

October 8, 2020, 6:41 am

≫ Next: Bio Roundup: CRISPR Kudos, Bristol Myers’s Buy, RNAi Alliance & More

≪ Previous: Bio Roundup: MESO’s Miss, Pfizer’s Cancer Bet, Vaccine Promise & More

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Science is the way out of this pandemic—and scientific breakthroughs are on the ballot on November 3. To help you get ready for Election Day, BIO’s initiative Biotech Votes has resources to help you get registered and get informed.

First, make sure you’re registered to vote. Check out this handy form to verify your voter information, find out your polling location, or request a mail-in ballot.

Then, get informed. This Biotech Votes 2020 Election Preview Report is an in-depth analysis of the races that matter the most, from the top of the ticket down the ballot to Senate, House, and state... Read more »

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Bio Roundup: CRISPR Kudos, Bristol Myers’s Buy, RNAi Alliance & More

October 9, 2020, 8:08 am

≪ Previous: BIO Launches ‘Biotech Votes’ Campaign to Encourage Registration and Informed Voting

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It’s October: a time of days growing shorter, leaves changing color, and phone calls in the wee hours that rouse scientists from slumber notifying them they’ve won the highest honor in their fields.

This week, the 2020 Nobel Prize in physiology or medicine was awarded to Harvey Alter, Michael Alton, and Charles Rice, whose research led to the discovery of the hepatitis C virus. Their work paved the way for blood tests and new medicines that can cure the infection. In chemistry, the Nobel was awarded to Emmanuelle Charpentier and Jennifer Doudna for their discovery of CRISPR/Cas9, a system that... Read more »

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