Boston

PharmaShots Weekly Snapshots (Aug 09 – 13, 2021)

Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma Published: Aug 13, 2021 | Tags: Junshi, Coherus, Toripalimab, US, FDA, Breakthrough Therapy Designation, Nasopharyngeal Carcinoma Celltrion’s Regdanvimab (CT-P59) Receives the ANVISA’s EUA for the Treatment of COVID-19 in Brazil Published: Aug 13, 2021 | Tags: Celltrion, Regdanvimab, …

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Second FDA clinical hold for Aprea cancer drug cites safety data in another study

For the second time in a week, the FDA placed a clinical hold on an Aprea Therapeutics cancer drug. The biotech said the agency cited safety and efficacy data from a prior failed clinical trial that tested the small molecule in a different form of cancer.

Boston’s EXALT Model B Single-Use Bronchoscope Receives the US FDA’s Clearance for Bronchoscopy Procedures

Shots: The US FDA has granted 510(k) clearance for EXALT Model B single-use Bronchoscope to use in bedside procedures within ICU and OR and will be available in the US in the coming wks. The device is being used for bronchoscopy procedures including secretion management, airway intubation, percutaneous tracheostomy, double-lumen endotracheal tube placement, and biopsies …

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FDA nod for Albireo drug makes it the first for children with rare liver disorder

The FDA has approved Bylvay, an Albireo Pharma drug that treats the severe itching experienced by patients with progressive familial intrahepatic cholestasis (PFIC). Prior to this approval, the only treatment options for the rare liver disorder were surgical.

AI-drug discovery biotech Valo Health is going public via a $2.8B SPAC merger

Valo Health is going public in a SPAC merger. Less than nine months removed from its formal launch, Valo is now revealing more about its artificial intelligence platform technology, which it plans to use to make the firm the first “digitally native” pharmaceutical company.

After getting FDA clearance for video game therapeutic, Akili faces next level: insurance coverage

Akili Interactive, a digital health company that got FDA clearance last year for its video game as treatment for ADHD, recently brought in $160 million in funding. It plans to use the funds to ramp up coverage of its flagship treatment and to develop digital treatments for other cognitive conditions. 

Biogen teams up with Ginkgo Bioworks in gene therapy manufacturing pact

Biogen is reaching across the Charles River, striking up a gene therapy manufacturing alliance with synthetic biology firm Ginkgo Bioworks. Ginkgo will use its technology to accelerate and make more efficient the process of manufacturing the AAV viral vectors used in gene therapies.

Vertex Pharma inks another R&D alliance to expand its gene-editing ambitions

Vertex Pharmaceuticals is collaborating with Obsidian Therapeutics to develop up to five new gene editing therapies. Obsidian’s technology precisely controls protein expression, a capability the partners plan to apply to several undisclosed serious diseases.

PharmaShots’ Key Highlights of First Quarter 2021

The first quarter of 2021 highlights new approvals, M&A, and the clinical data of COVID-19 vaccines. The companies expand their working in COVID-19 by targeting South African & Brazil variants along with other emerging variants Starting with the latest acquisition, Amgen acquired Five Prime for $1.9B, Jazz acquired JW while Boston acquired Preventice. This quarter …

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Vertex to pay CRISPR Therapeutics $900M for bigger share of gene-editing alliance

Vertex Pharmaceuticals is amending its collaboration with CRISPR Therapeutics, paying $900 million now for chance to grab a bigger share of a gene-editing therapy’s profits later—if the treatment is approved. Clinical trials evaluating the CRISPR-based therapy are underway in sickle cell disease and beta thalassemia.

OrbiMed-incubated Theseus unveils $100M to beat cancer drug resistance

Incubated by OribMed and led by Ariad Pharmaceuticals veterans, Theseus Pharmaceuticals unveiled $100 million in Series B financing to develop the next generation of tyrosine kinase inhibitors, a type of cancer drug. The company expects to enter the clinic by the end of 2021.

Leyden Labs unveils €40M for medicines that could prevent Covid-19 & more

Founded by scientists behind the technology used in Johnson & Johnson’s Covid-19 vaccine, Leyden Laboratories is developing intranasal medicines intended to stop viruses before they infect the lungs. SARs-CoV-2 is one target, but the startup plans to address many respiratory pathogens.

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, …

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PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, …

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Boston Signs Out-License and Option Agreement with GSK to Advance Two Programs for Oncology and CNS Disorders

Shots: Boston will lead the development of selected programs through PoC. GSK gets an option to reacquire each program under pre-agreed terms for development and WW commercialization, after completion of POC studies If GSK exercises its repurchase option, Boston to receive a one-time payment and milestones along with royalties. If GSK selects not to reacquire …

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Boston Signs Out-License and Option Agreement with GSK to Advance Two Programs for Oncology and CNS Disorders

Shots: Boston will lead the development of selected programs through PoC. GSK gets an option to reacquire each program under pre-agreed terms for development and WW commercialization, after completion of POC studies If GSK exercises its repurchase option, Boston to receive a one-time payment and milestones along with royalties. If GSK selects not to reacquire …

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Benefits of Turmeric for Arsenic Exposure

What happened when turmeric curcumin was put to the test to see if it could reverse DNA damage caused by arsenic exposure? Arsenic is a carcinogenic heavy metal, and the major mechanism of arsenic-related damage appears to be oxidative stress. It’s the arsenic-induced accumulation of free radicals that can kill off cells and damage our …

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Roivant extends AI drug discovery reach with $450M Silicon Therapeutics buyout

Roivant Sciences is expanding its drug discovery and design capabilities via a stock deal to acquire Silicon Therapeutics. The Boston startup uses physics-based modeling to simulate proteins and the small molecules that bind to them.

Folx raises $25M to expand direct-to-consumer health platform for LGBTQ patients

Folx, a direct-to-consumer health startup for LGBTQ patients, raised $25 million in funding. The company, which launched in December and currently operates in 11 states, plans to use the funds to further expand its footprint and expand into sexual health and family planning services.

PharmaShots Weekly Snapshots (Jan 18 – 22, 2021)

Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC Published: Jan 22, 2020 | Tags: Takeda, Alunbrig, (brigatinib), Receives, MHLW, Approval,1L and 2L, Treatment, ALK+ Advanced or Recurrent NSCLC MTPA and Aquestive Sign a License and Supply Agreement for Exservan (riluzole) to Treat ALS in the …

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Armed with $270M in capital, Scorpion Therapeutics aims to broaden the reach of precision oncology

Founded in 2020, Scorpion is agnostic about the potential therapies and targets it will explore with what it describes as its drug-hunting engine. But the company is hoping to unveil its first drug candidate this year.

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, Transdermal Contraceptive Patch Assets, Treat Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC Published: Dec 3, 2020 | Tags: ATLANTIS, Doxorubicin, …

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Boston Scientific to Divest BTG’s Specialty Pharma Business for ~$800M

Shots: Boston Scientific signs an agreement with Stark International and SERB SAS to sell its BTG specialty pharma business for $800M in cash. The transaction is expected to close in H1’21 The agreement includes the transfer of 5 facilities & ~280 employees globally. This transaction will help the BTG specialty pharma business enhance its potential …

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PharmaShots Weekly Snapshot (Nov 02-06, 2020)

AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack Published: Nov 6, 2020 | Tags: AstraZeneca, Brilinta, ticagrelor, Receives, US FDA, Approval, Acute, High,Risk, Transient, Ischaemic, Stroke Novo Nordisk to Acquire Emisphere Technologies for $1.8B Published: Nov 6, …

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PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020)

Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout Published: Oct 1, 2020 | Tags: Chronic Refractory Gout, COMPARE Study, Important Clinical Improvement, P-II, patients, reports, results, SEL-212, Selecta Biosciences, Sobi 2. Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults Published: Oct 1, 2020 | Tags: COVID-19, …

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Study uses genomic data to trace Covid-19 ‘superspreader’ event linked to February Biogen exec meeting

The study, by researchers at Harvard, MIT, The Broad and other institutions, used genomic analysis of cases linked to the Biogen meeting, linking much of the community transmission in the Boston area to a European genetic variant of SARS-CoV-2 that first appeared at the meeting.

Alexion drops kidney disease program for drug that was part of $930M Achillion buyout last year

The company said in its 2Q earnings that it would halt development of ALXN2040 for C3 glomerulopathy, or C3G, citing the drug’s lack of potency. However, it may develop a second, more potent drug from the Achillion acquisition, ALXN2050, in the same disease.

TEDMED 2020 Meetups

TEDMED Meetups, uniquely designed conversations, engage the entire TEDMED community to share their individual perspectives and voices to help improve humanity’s health. Read on to view some of the details of these captivating conversations taking place at TEDMED 2020. Meetup 1 Tuesday, March 3rd, 8:00 am- 8:45 am Climate and Culture, A Health Equity Conversation …

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