A parallel Marketing Authorization application has also been submitted to the European Medicines Agency (EMA) in support of a type II variation and line extension for expanded pediatric use in Europe.

If the new applications are approved, EDURANT, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, could be administered to younger pediatric patients via standard 25 mg tablets or new 2.5 mg tablets for oral dispersion that were developed to aid administration and weight-adjusted dosing for children.

“We’ve been working to fight HIV for decades and are proud to have helped bring forward nine medicines for people living with HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen Research & Development, LLC. “These filings are the latest example of our longstanding work to make different treatment options available to meet the diverse needs of people living with HIV.”

The expanded pediatric applications are supported by data from the Phase 2 PAINT and PICTURE studies, which showed that EDURANT, in combination with other antiretroviral therapies, effectively maintains or suppresses the virus in treatment-experienced and treatment-naive pediatric patients, respectively. Given these data, Janssen is seeking an expanded indication to allow use in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) and treatment-experienced virologically suppressed children (with HIV-1 RNA <50 copies/mL) weighing 10 kg or more.

In 2022, the FDA approved the world’s first long-acting injectable HIV-1 treatment option for adolescents 12 years of age and older. This regimen consists of Janssen’s long-acting rilpivirine and ViiV Healthcare’s long-acting cabotegravir and requires as few as six treatments per year.

Read also: Phase 3 trial of Rybrevant plus chemotherapy in lung cancer meets primary endpoint: Janssen

Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four vaccine viruses

Osaka: Takeda has announced that the Company has voluntarily withdrawn the U.S. Biologics License Application (BLA) for its dengue vaccine candidate, TAK-003, following discussions with the U.S. Food and Drug Administration (FDA) on aspects of data collection, which cannot be addressed within the current BLA review cycle.

The future plan for TAK-003 in the U.S. will be further evaluated given the need for travelers and those living in dengue-endemic areas of the U.S., such as Puerto Rico. The vaccine is approved in multiple endemic and non-endemic countries, with more approvals expected over the coming years.

“Our clinical program was designed to account for the complex global nature of dengue, and data from our 4.5-year trial has built confidence in TAK-003’s ability to help provide long-term protection against dengue, with a positive benefit and risk profile regardless of baseline serostatus,” said Gary Dubin, M.D., president of Takeda’s Vaccines Business Unit. “The urgent global need to combat the growing burden of dengue remains, and we will continue to progress regulatory reviews and provide access for people living in and traveling to dengue-endemic areas while we work to determine next steps in the U.S.”

The efficacy and safety profiles of TAK-003 have been demonstrated through a robust clinical trial program, including a 4.5-year Phase 3 study of over 20,000 children and adolescents living in eight dengue endemic areas. The study was designed per World Health Organization (WHO) guidance for a second-generation dengue vaccine, and it considered the need to achieve high levels of subject retention and protocol compliance in endemic regions.

Last year, TAK-003 received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) after going through the EU-M4all process, a parallel review of the vaccine for use in the EU and participating dengue endemic countries around the world. The vaccine has since been approved in the EU, United Kingdom, Brazil, Argentina, Indonesia, and Thailand.

Dengue is a global public health crisis and further prevention measures are needed to support the millions of individuals around the world exposed to dengue.

Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four vaccine viruses.

Read also: Taked Dengue Tetravalent Vaccine QDENGA gets European Commission nod

The EIR was issued post the last inspection of the facility conducted from March 21 to March 29, 2023. The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).

VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

“We are pleased to have received the EIR from the US FDA with a satisfactory VAI status for our Pithampur Unit-2 facility. This is a significant milestone as we build back our reputation of being best-in-class in Quality and Compliance. We look forward to new products approvals and launches, especially ophthalmic products from this facility now,” said Nilesh Gupta, Managing Director, Lupin.

Read also: USFDA inspection: Lupin gets 10 observations for Pithampur facility

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Read also: Lupin CSR arm, Maharashtra Govt collaborate to address growing prevalence of cardiovascular diseases, COPD

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23.

Lupin has 15 manufacturing sites, 7 research centers, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

Read also: Lupin gets USD 25 million from AbbVie for novel MALT1 inhibitor program to treat hematological cancers

Mumbai: Global pharma major Lupin Limited today announced that
it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for
its Abbreviated New Drug Application (ANDA), Dolutegravir Tablets for Oral Suspension, 5 mg.

The product is a generic equivalent of Tivicay PD Tablets for Oral Suspension, 5 mg of ViiV Healthcare
Company.

Dolutegravir is an antiretroviral medication used, together with other medications, for the treatment of HIV/AIDS.

This product will be manufactured at Lupin’s Nagpur facility in India.
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD ) had estimated annual sales of USD
1 million in the U.S. (IQVIA MAT March 2023).

Read also: Lupin bags USFDA nod for generic equivalent of Nascobal Nasal Spray

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The
Company develops and commercializes a wide range of branded and generic formulations, biotechnology
products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin
America (LATAM), Europe, and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has
a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s
health areas. The company
invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has
been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.Read also: Lupin receives over Rs 205 crore from AbbVie for meeting key product development milestone

The product is a generic equivalent of Nascobal Nasal Spray, 500 mcg/spray of Par Pharmaceutical, Inc. This product will be manufactured at Lupin’s Somerset facility in the US.

Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023).

Cyanocobalamin is a form of vitamin B12 used for the treatment of deficiency of vitamin B12.

Read also: Lupin CSR arm, Maharashtra Govt collaborate to address growing prevalence of cardiovascular diseases, COPD

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23.

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

Read also: Lupin gets USD 25 million from AbbVie for novel MALT1 inhibitor program to treat hematological cancers

The company has achieved a key milestone for its novel MALT1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1) inhibitor program that is partnered with AbbVie Inc towards treatment across a range of hematological cancers, the Mumbai-based drug maker said in a statement.

As part of the agreement, Lupin has received USD 25 million from AbbVie for initiation of Phase 1 clinical studies successfully, it added.

The drug maker had earlier received USD 30 million from AbbVie for achievement of other milestones in the programme.

Read Also: Lupin Unveils Rufinamide Oral Suspension For Seizure Disorder In US

"This achievement is further validation of our ability to successfully develop novel treatments for unmet needs. We look forward to continued successful development of this important treatment for patients with difficult-to-treat cancers," Lupin Managing Director Nilesh Gupta said in a statement.

Lupin and AbbVie inked the licensing, development, and commercialisation agreement in 2018 for a novel oncology drug to treat hematological cancers.

The company said its novel drug discovery and development (NDDD) team is focused on building a pipeline of highly differentiated and innovative new chemical entities in the oncology space.

Read Also: Lupin Receives Over Rs 205 Crore From AbbVie For Meeting Key Product Development Milestone

Mumbai: Global pharma major Lupin Limited has announced the
achievement of a key milestone for its novel MALT1 (Mucosa-Associated Lymphoid Tissue
Lymphoma Translocation Protein 1) inhibitor program that is partnered with AbbVie Inc. towards treatment across a range of hematological cancers.

As part of the agreement, Lupin has received USD 25 million from AbbVie for initiation of Phase 1
clinical studies successfully. Lupin had earlier received USD 30 million from AbbVie for achievement
of other milestones in the program.

Lupin and AbbVie inked the licensing, development, and commercialization agreement in 2018 for
this novel oncology drug to treat Hematological Cancers. Lupin’s MALT1 inhibitor developed as part
of its oncology pipeline had previously shown pre-clinical activity as a single agent as well as in
combination.

“This achievement is further validation of our ability to successfully develop novel treatments for
unmet needs. We look forward to continued successful development of this important treatment for
patients with difficult-to-treat cancers,” said Nilesh Gupta, Managing Director, Lupin. 

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The
Company develops and commercializes a wide range of branded and generic formulations, biotechnology
products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin
America (LATAM), Europe, and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has
a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s
health areas. The company
invested 7.9% of its revenue in research and development in FY23.Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has
been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

Read also: Lupin unveils Rufinamide Oral Suspension for seizure disorder in US

GEMCOVAC-OM is the first booster COVID-19 vaccine developed in India against the highly transmissible Omicron variant. GEMCOVAC-OM has demonstrated robust immune responses in the phase 3 clinical trial conducted at 20 centers across 13 cities in India In Phase-II/ III trials, approximately 3000 individuals received GEMCOVAC-OM and the vaccine was safe and well tolerated.

The currently approved vaccines used as precautionary/ booster doses are designed against the ancestral strain of SARS-CoV-2. Although these will increase the antibody titers, their ability to neutralize the circulating Omicron variant of SARS-CoV-2 is limited. Developing antibodies and memory immune responses specific to the Omicron variant would reduce the probability of infection and hospitalization and prevent future waves of the pandemic. The Made-in-India GEMCOVAC-OM specifically addresses this gap.

GEMCOVAC-OM is a lyophilized (freeze dried) vaccine, stable at 2- 8 °C.

It is delivered intradermally using a device called Tropis, developed by PharmaJet, USA. This is a needle-free device that obviates the disadvantages of using a needle, such as a needle phobia, sharps disposal, and needle-stick injuries, to name a few.

Dr. Sanjay Singh, CEO, Gennova Biopharmaceuticals Limited, said, “The Gennova team, as a part of the global scientific community’s endeavour to meet unmet medical needs, is geared for dealing with health emergencies. There is a realization that the COVID-19 will remain and keep mutating, and therefore we need to be prepared with vaccines to deal with emerging variants, The mRNA platform, that was developed in association with the Department of Biotechnology, Government of India, provides an opportunity for a quick turnaround for vaccine development for any variants of concern in future, if any. Vaccines have remained the best shield for mankind against deadly diseases.”

Reiterating Gennova’s pursuit of research for finding solutions for better health, Mr. Samit Mehta, COO, Gennova Biopharmaceuticals Limited, said, “Gennova has successfully developed India’s first Omicron-variant vaccine within a few months. Being aware of the accessibility challenges the world witnessed for the COVID-19 vaccines, we are happy that we are providing a vaccine based on a state-of-the-art technology, the mRNA. We are thankful to our stakeholders – medical fraternity, government, scientific community - for espousing confidence in our effort towards the mRNA technology and now the Omicron specific vaccine. The mRNA vaccine platform continues to remain a protective shield for India and the world against Coronavirus”.

Read also: NTAGI to discuss data of Gennova Pharma mRNA vaccine against COVID

Earlier this month, Coherus had said it would launch a biosimilar version of AbbVie's Humira, at an 85% discount to the list price of about $6,922, and partnered with Mark Cuban Cost Plus Drug Company to sell it at $569.27.

AbbVie had alleged a breach of an older agreement that granted Coherus a non-exclusive license to commercialize a biosimilar version of Humira in the United States from July 1.

In response, Coherus filed a restraining order against AbbVie to keep it from terminating the licensing deal.

This was followed by a preliminary injunction against Coherus, which still remains in place, though the companies have agreed that AbbVie would not terminate its licensing deal based on the notice.

The companies also agreed that AbbVie would have to serve another notice and give Coherus time to resolve the breach if it chooses to terminate the licensing agreement.

Read also: AbbVie plan to withdraw accelerated nods of Imbruvica in US for patients with certain types of blood cancer

Chennai: Caplin Steriles Limited, a Subsidiary company of Caplin Point
Laboratories Limited, has been granted final
approval by the United States Food and Drug Administration (USFDA) for its Abbreviated
New Drug Application (ANDA) Cisatracurium Besylate Injection USP, 10 mg/5 mL (2 mg/mL)
and 200 mg/20 mL (10 mg/mL) Single-dose Vials; and 20 mg/10 mL (2 mg/mL) Multiple-dose
Vials (Preserved).

The product is a generic therapeutic equivalent version of (RLD), NIMBEX injection of
AbbVie Inc.

Cisatracurium Besylate Injection USP is a nondepolarizing skeletal neuromuscular blocker,
indicated as an adjunct to general anesthesia to facilitate tracheal intubation and to provide
skeletal muscle relaxation during surgical procedures.

According to IQVIA (IMS Health),
Cisatracurium Besylate Injection USP had US sales of approximately $35 million for the 12-
month period ending December 2022. 

C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited commented, “We’ve
been consistent with our filings and also happy to receive approvals on time. We’re creating a
healthy portfolio of products that we will launch not only in the US but in global markets as
well. This approval will augment our growth plans for Caplin Steriles this year and the years
going forward.”

Read also: Caplin Steriles bags USFDA nod for Ketorolac Tromethamine Injection

Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a niche sterile
product manufacturing company that is approved by several regulatory agencies such as US
FDA, EU-GMP and ANVISA. Caplin Steriles Limited, has developed and filed 30 ANDAs in USA
on its own and with partners, with 23 approvals so far, including this approval. The Company
is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products,
that it intends to file over the next 4 years.

Read also: USFDA nod to Caplin Steriles Rocuronium Bromide Injection