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Gatehouse Bio collaborates with AstraZeneca to accelerate new drug discovery
Published:

Gatehouse Bio’s ‘sRNAlytics platform’ identifies novel small RNA (sRNA) signatures and illuminates molecular pathways correlated to and potentially driving disease. “Our annotation library of over 1.4M small RNA

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Bristol-Myers Squibb gets FDA breakthrough therapy status for Orencia to prevent GvHD
Published:

GvHD is a potentially life-threatening medical complication, which can affect patients receiving such transplants to treat certain genetic diseases and haematologic cancers. Orencia is an immunomodulator that disturbs

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AWS announces strategic collaboration with Novartis to accelerate digital transformation of its business operations
Published:

This enterprise-wide data and analytics platform is expected to form the foundation for custom solutions powered by AWS AI and ML services to help drive agility, innovation, and

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FDA Approves First Gilenya Generics
Published: 5 Dec 2019 | 23:12 UTC

Novartis’ blockbuster multiple sclerosis drug Gilenya (fingolimod) may soon face generic competitors in the U.S., following three FDA approvals.

CDER Recaps New Drug Approvals in 2019, Looks Ahead to 2020
Published: 5 Dec 2019 | 23:11 UTC

The FDA continued to lead the world in new molecular entity approvals in fiscal year 2019, according to a senior official in the Office of New Drugs.

Agenda - CAT agenda of the 4-6 December 2019 meeting
Published: 5 Dec 2019 | 15:48 UTC

Agenda - CAT agenda of the 4-6 December 2019 meeting

Pharma disruptors, challenges and opportunities
Published: 5 Dec 2019 | 14:32 UTC

The recent Financial Times Global Pharmaceutical and Biotechnology Conference provided two days of fascinating insights into the pharma industry, with discussions around the key challenges, disruptors and opportunities it is facing. Covering topics ranging from artificial intelligence to alternative funding options, and patient-centered care to pricing, the meeting brought together experts from across the healthcare ecosystem. The panel discussions, on which this post focuses, were especially valuable for highlighting and stimulating talk on topics and themes crucial to the industry.

Patient-centric care and the role of digital technology

A panel discussion centering on the pharma industry’s relationship with the patient began with an audience poll asking which players are best placed to build strong and commercially beneficial relationships with patients. Physicians and healthcare workers garnered a strong 41% of the votes, but with a very close challenge (40%) from the tech industry as an incoming disruptor in the field. The insurance industry trailed the field at 5%, with the pharma industry taking the middle ground with 14% of the vote. Jessica Scott (Head of R&D Patient Engagement Office, Takeda) noted that strict regulations have made direct communications with patients difficult, and the pharma industry has had to come up with new ways to communicate.

 

“41% of the attendees saw physicians and healthcare workers as best placed to build relationships with patients, while the tech industry, an incoming disruptor, came a close second at 40%“

Technology is clearly a strong force in the patient communication sphere. Dan Vehdat (CEO & Founder, Medopad) commented that real-time relationships with patients are now possible due to technology, and Lord Drayson (CEO Sensyne Health) added that technology has a huge role to play but must be used in a way to maintain society’s trust. Pharma is well placed to do this, Lord Drayson said, as pharma, in conjunction with strong regulation, has developed a lot of patient trust and confidence. The industry must now engage and show how technology can be used in a responsible way.

Eddie Martucci (CEO & Co-Founder, Akili Interactive Labs) expanded on this theme, commenting that pharma is entering an interesting phase, and what is needed is an evolution of a new industry. Consumers are getting stronger at asking for what they want, and the key to a good pharma-patient relationship is giving patients something that provides immediate value back to them. Digital therapeutics, for example, could take data from the patient, act on and evolve from that input, and return better value to the patient based upon it. Pure data monetization is not really aligned with patient interests, Dr. Martucci said; data should instead be used to improve the service provided to the patient.

This viewpoint was echoed by Hanno Ronte (Monitor Deloitte), who stated that trust comes from the individual patient experience and that the biggest value that can be obtained from data is optimizing the patient’s pathway through treatment. Data is an ecosystem, he said, with data sharing and reciprocity required. Dr Scott agreed, adding that data from clinical trials should be returned to the patient in order to build trust, and that it is down to the pharma industry to establish ways to do this. Pharma is moving from a transactional to a partnership model, Lord Drayson added.

To download the full report from the Financial Times Global Pharmaceutical and Biotechnology Conference, which additionally includes coverage of sessions on pricing and value, alternative funding options, regulatory system evolution, artificial intelligence, the emerging role of China, and the value of the pharma industry, complete the form to the right.

Digital health technologies play a large role in patient experience. Understand what’s happening across the digital health ecosystem with coverage spanning digital health players and activities in life sciences, technology, electronics, software and healthcare markets. To learn more visit: clarivate.com/cortellis-digital-health-intelligence

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Workshop on the role of registries in the monitoring of cancer therapies based on genetic and molecular features, European Medicines Agency, Amsterdam, the Netherlands, from 29/11/2019 to 29/11/2019
Published: 5 Dec 2019 | 14:30 UTC

Workshop on the role of registries in the monitoring of cancer therapies based on genetic and molecular features, European Medicines Agency, Amsterdam, the Netherlands, from 29/11/2019 to 29/11/2019

Ivermectin (systemic use): List of nationally authorised medicinal products - PSUSA/00010377/201904
Published: 5 Dec 2019 | 14:02 UTC

Ivermectin (systemic use): List of nationally authorised medicinal products - PSUSA/00010377/201904

Zionexa Has Signed an Exclusive Agreement With PETNET Solutions Inc. for Manufacturing and Distribution
Published: 5 Dec 2019 | 0:00 UTC

Zionexa, a radiopharmaceutical company specialized in the development and commercialization of in-vivo biomarkers for use in guiding targeted therapies in oncology, and PETNET Solutions Inc., a Siemens Healthineers company specializing in the manufacturing and distribution of positron emission tomography (PET) biomarkers, have entered into an exclusive agreement for the manufacturing and distribution of Zionexa’s new PET diagnostic drug, Fluoroestradiol

Generex Biotechnology Announces Funding Update
Published: 5 Dec 2019 | 0:00 UTC

Generex Biotechnology Corporation (OTCQB: GNBT) is pleased to announce that the company has finalized agreements to provide significant funding for ongoing operations, launching new businesses, and advancing the commercial development of new products from the NuGenerex family of companies

ViiV Healthcare submits New Drug Application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available
Published: 5 Dec 2019 | 0:00 UTC

Fostemsavir is being developed for use in combination with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are unable to form a suppressive regimen due to resistance, intolerance or safety considerations.

RenovaCare Stockholder Update and 2020 Outlook from the CEO
Published: 5 Dec 2019 | 0:00 UTC

RenovaCare, Inc. (Symbol: RCAR), developer of patented technologies for spraying self-donated stem cells for the regeneration of skin and other organs and tissues, is pleased to provide this update from its new CEO, Mr. Alan L. Rubino, as well as his outlook for 2020.

ViiV Healthcare submits New Drug Application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available
Published: 5 Dec 2019 | 0:00 UTC

Fostemsavir is being developed for use in combination with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are unable to form a suppressive regimen due to resistance, intolerance or safety considerations.

FDA approves first generics of Gilenya
Published: 5 Dec 2019 | 0:00 UTC

The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.

Meitheal Pharmaceuticals Announces FDA Approval of Enoxaparin Sodium Injection, USP in the United States
Published: 5 Dec 2019 | 0:00 UTC

Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated generic injectables company today announced that the US Food and Drug Administration (FDA) has approved Enoxaparin Sodium Injection, USP, the generic equivalent of Lovenox®.

Meitheal Pharmaceuticals Announces FDA Approval of Enoxaparin Sodium Injection, USP in the United States
Published: 5 Dec 2019 | 0:00 UTC

Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated generic injectables company today announced that the US Food and Drug Administration (FDA) has approved Enoxaparin Sodium Injection, USP, the generic equivalent of Lovenox®.

FDA approves first generics of Gilenya
Published: 5 Dec 2019 | 0:00 UTC

The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.

VivaLnk Earns CE Mark for Multi-Vital Wearable Sensor and SDK
Published: 4 Dec 2019 | 18:59 UTC

The reusable sensor patch weighs 7.5 grams.

Nanomix’s POC Diagnostic for Serious Infections Gains CE Mark
Published: 4 Dec 2019 | 18:56 UTC

The panel is designed to quickly detect life-threatening infections like sepsis and bacteremia.

EmCyte’s Concentrating System Cleared for Gathering Autologous Adipose Tissue
Published: 4 Dec 2019 | 18:55 UTC

The system uses “powerful regenerative bioactive substances to work on transferred tissue without hindering influences,” the company said.

Q3 2019 M&A highlights
Published: 4 Dec 2019 | 8:41 UTC

We’ve recently wrapped up analysis of Q3 2019 M&A activity around the world.  Here are a few highlights:

Q3 2019 new M&A volume and total deal value increased by 4% and 10%, respectively

Total disclosed biopharma mergers and acquisitions (M&A) volume increased slightly in the third quarter of 2019, up 4% from 140 new M&As in Q3 2018 to 146 in the same quarter this year. Total disclosed deal value increased by 10% to $21.7 billion from $19.7 billion (Figure 1).

 

Figure 1: M&A deal activity in the third quarters of 2015-2019
Source: Cortellis Deals Intelligence

 

Fourteen high-value new M&As tracked, each worth in excess of $500 million

The third quarter of 2019 saw 14 high-value new M&As, each worth in excess of $100 million. Fourteen of those M&As were worth more than $500 million each, representing 83.5% of the total disclosed figure of $21.7 billion.

 

Top deals and dealmakers

Sumitomo Dainippon Pharma formed an alliance with Roivant Sciences, including its 46% ownership interest in Myovant Sciences, for $3 billion, including a 10% equity stake. In addition, Vertex Pharmaceuticals is acquiring Semma Therapeutics for approximately $950 million in cash as it seeks to progress the biotech’s pluripotent stem cell therapy into clinical development for Type I diabetes. And, Lundbeck approached Alder BioPharmaceuticals for up to $1.95 billion ($18.00/share in cash up front and one non-tradeable contingent value right of $2.00/share) upon EU approval of Alder’s lead asset eptinezumab.

 

Low levels of M&A activity across APAC

Companies based in the Asia Pacific (APAC) region generated a collective 14 M&As, a 26% decrease from 19 in the same quarter of 2018. At the same time, the total disclosed deal value increased to $3.8 billion, a 13% increase from Q3 2018 (see Figure 2).

Figure 2: Total disclosed M&A deal value and M&A deal volume by APAC-based companies
Source: Cortellis Deals Intelligence

 

Key takeaways

In summary, M&A activity seems to be flat as companies potentially look at other options to raise capital as well as pursue licenses and collaborations as means of progressing asset development and commercialization.  Anti-trust concerns prior to horizontal and vertical integration of target companies may also be on the rise, further inhibiting activities.


For a full analysis, including a deeper look at key M&As, a review of target portfolios by APAC companies, and an early outlook on Q4 2019 high-value and diversified M&As, read the full report (available for download to the right of this post).

Note: All data contributing to this analysis was sourced from Cortellis Deals Intelligence from Clarivate Analytics.  

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FDA Approves Genentech’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for The Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
Published: 3 Dec 2019 | 20:12 UTC

South San Francisco, CA -- December 3, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) in combination with chemotherapy...

Human medicines European public assessment report (EPAR): Rhokiinsa, netarsudil, Glaucoma, Open-Angle,Ocular Hypertension, Date of authorisation: 19/11/2019, Status: Authorised
Published: 3 Dec 2019 | 10:26 UTC

Human medicines European public assessment report (EPAR): Rhokiinsa, netarsudil, Glaucoma, Open-Angle,Ocular Hypertension, Date of authorisation: 19/11/2019, Status: Authorised

Lexicon Loses Appeal of Complete Response Letter for Diabetes Treatment
Published: 2 Dec 2019 | 23:01 UTC

Lexicon Pharmaceuticals has lost its appeal to the FDA of the agency’s complete response letter in March for its investigational add-on type 1 diabetes treatment Zynquista (sotagliflozin).

FDA Approves RediTrex (methotrexate) for Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, and Psoriasis
Published: 2 Dec 2019 | 20:12 UTC

NASHVILLE, Tenn., Dec. 2, 2019 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for RediTrex, its new...

Human medicines European public assessment report (EPAR): Senstend, lidocaine / prilocaine, Premature Ejaculation, Date of authorisation: 14/11/2019, Status: Authorised
Published: 29 Nov 2019 | 13:34 UTC

Human medicines European public assessment report (EPAR): Senstend, lidocaine / prilocaine, Premature Ejaculation, Date of authorisation: 14/11/2019, Status: Authorised

India: The emerging hub for biologics and biosimilars
Published: 29 Nov 2019 | 4:30 UTC

The global pharmaceutical industry is facing a shift from chemical-based drugs to biologics and biosimilars. While small molecule therapeutics had previously dominated research and captured major market share, the advent of large molecule therapeutics (biologics and biosimilars) has rapidly transformed the pharmaceutical industry.

Given their targeted mechanism of action and reduced toxicity, biologics have gained major market share in terms of both revenue and total market, which was USD 200bn in 2013 and is expected to grow to USD 386bn by the end of 2019 at a compound annual growth rate (CAGR) of 10%. Most recent blockbuster drugs (defined by annual revenue greater than USD 1bn) are novel biologics.

However, while biologics pave the way in innovative standards of care, they represent the most expensive of treatments. There is global consensus on the need to reduce the price of treatment, something that biosimilars may help to address. We estimate that the global biosimilars market opportunity will grow to more than USD 70bn by 2027[1]. Recent regulatory approvals in developed markets, combined with the upcoming patent expirations of more than 10 blockbuster biologics (total revenue of USD 60bn) within the next two to three years, provide a further boost to the biosimilars market.

 

The Indian government’s initiatives to promote biotech-based drug development

Indian regulatory authorities approved the first biosimilar in 2000, and 98 biosimilars from then through September 2019. The number of approvals in India over the last five years represents a robust opportunity for biologics and biosimilars.

Association of Biotechnology Led Enterprises (ABLE) in India estimates the biologics market to grow at a compound annual growth rate (CAGR) of 22% to reach USD 12bn by 2025.

In response to the high commercial potential and the need for development of indigenous drugs to cater to the large Indian population, the government of India has taken steps to encourage India’s development as a hub for biotechnology-based drugs. The Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC) are working in close collaboration with the industry and academia on multiple initiatives to promote research and manufacturing in biotechnology-based drugs. Initiatives include:

We predict that the current push for R&D in biotechnology research will establish India as one of the top biotechnology destinations across the globe.

For a full analysis, including a deeper look at the emerging global biotherapeutics landscape, download the report, India: The emerging hub for biologics and biosimilars, via the form to the right of this post.


[1] https://www.marketsandmarkets.com/PressReleases/global-biosimilars-product-market-worth-19.4-billion-by-2014.asp

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Human medicines European public assessment report (EPAR): Arsenic trioxide Accord, arsenic trioxide, Leukemia, Promyelocytic, Acute, Date of authorisation: 14/11/2019, Status: Authorised
Published: 26 Nov 2019 | 14:36 UTC

Human medicines European public assessment report (EPAR): Arsenic trioxide Accord, arsenic trioxide, Leukemia, Promyelocytic, Acute, Date of authorisation: 14/11/2019, Status: Authorised

Evofem Biosciences Resubmits New Drug Application to U.S. FDA for Amphora® for the Prevention of Pregnancy
Published: 26 Nov 2019 | 3:11 UTC

SAN DIEGO, Nov. 26, 2019 /PRNewswire/ -- Evofem Biosciences, Inc. (NASDAQ: EVFM), a clinical-stage biopharmaceutical company, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug...

FDA Approves Oxbryta (voxelotor) for the Treatment of Sickle Cell Disease
Published: 25 Nov 2019 | 21:11 UTC

SOUTH SAN FRANCISCO, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) --  Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval...

Lung cancer: AI shows who will benefit from immunotherapy
Published: 25 Nov 2019 | 15:00 UTC

A team of researchers has developed a machine learning model able to predict which individuals with lung cancer will most benefit from immunotherapy.

Zogenix Announces FDA Acceptance for Filing of New Drug Application and Priority Review for Fintepla for the Treatment of Dravet Syndrome
Published: 25 Nov 2019 | 2:11 UTC

EMERYVILLE, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the...

Sunovion Resubmits New Drug Application for Apomorphine Sublingual Film
Published: 22 Nov 2019 | 2:11 UTC

MARLBOROUGH, Mass.--(BUSINESS WIRE) November 22, 2019 --Sunovion Pharmaceuticals Inc. (Sunovion) today announced the resubmission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apomorphine sublingual film...

The rise of superbugs: Facing the antibiotic resistance crisis
Published: 18 Nov 2019 | 17:00 UTC

Policymakers have warned that we face an antibiotic resistance crisis. Why is this, what are researchers doing to address it, and what can we do right now?

New therapeutic approach may improve outcomes in sepsis and stroke
Published: 8 Nov 2019 | 15:00 UTC

An innovative method that researchers have tested in mouse models could help fight harmful inflammatory responses triggered by sepsis and stroke.

Soft robotics breakthrough manages immune response for implanted devices
Published: 4 Sep 2019 | 18:46 UTC

Discovery could enable longer-lasting and better-functioning devices — including pacemakers, breast implants, biosensors, and drug delivery devices. Institute for Medical Engineering and Science Researchers from the Institute for Medical Engineering and Science (IMES) at MIT; the National University of Ireland Galway (NUI Galway); and AMBER, the SFI Research Centre for Advanced Materials and BioEngineering Research, […]

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Ultrasound Breakthrough Could Eliminate Endoscopy
Published: 5 Aug 2019 | 17:34 UTC

By Emily Durham  One day, scopes may no longer need to be inserted into the body, such as down the throat or under the skin, to reach the stomach, brain, or any other organs for examination. Maysam Chamanzar, assistant professor of electrical and computer engineering at Carnegie Mellon University, and Matteo Giuseppe Scopelliti, an ECE Ph.D. student, […]

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Two UB centers create a new platform on neurotoxicology and drug testing based on stem cells
Published: 8 May 2019 | 21:51 UTC

Recerca The Production and Validation Center for Advanced Therapies (Creatio) and the Research Centre on Toxicology (CERETOX) through the Unit of Experimental Toxicology and Ecotoxicology (UTOX) from the Barcelona Science Park (PCB), entities of the University of Barcelona with the Tecnio seal, have created the platform Avantdrug. The new platform offers services to companies and […]

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New gene therapy to treat rare inherited blood condition
Published: 1 Apr 2019 | 20:36 UTC

EMA has recommended granting a marketing authorisation in the European Union for a genetically modified product for beta-thalassaemia, a rare inherited blood condition that causes severe anaemia. Zynteglo is intended for adult and adolescent patients 12 years and older who need regular blood transfusions to manage their disease and have no matching donor for a stem cell […]

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New optical imaging system could be deployed to find tiny tumors
Published: 11 Mar 2019 | 16:39 UTC

Near-infrared technology pinpoints fluorescent probes deep within living tissue; may be used to detect cancer earlier. Anne Trafton | MIT News Office  Many types of cancer could be more easily treated if they were detected at an earlier stage. MIT researchers have now developed an imaging system, named “DOLPHIN,” which could enable them to find […]

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Cryptographic protocol enables greater collaboration in drug discovery
Published: 22 Oct 2018 | 13:50 UTC

Neural network that securely finds potential drugs could encourage large-scale pooling of sensitive data. Rob Matheson | MIT News Office MIT researchers have developed a cryptographic system that could help neural networks identify promising drug candidates in massive pharmacological datasets, while keeping the data private. Secure computation done at such a massive scale could enable […]

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